Staska Pharmaceuticals: FDA Warning Letter Record (May 5, 2025) — the registered facility whose bulk drug substance came from an unregistered establishment

Published September 17, 2026

On May 5, 2025, FDA sent warning letter 699291 to Staska Pharmaceuticals, Inc. of Bennet, Nebraska. Staska is not an offshore website. It is a facility that registered with FDA as a 503B outsourcing facility — the regulated compounding lane that people in this market often point to as the legitimate one. It had been registered since December 3, 2020. It makes sterile drug products in batches. And FDA's first finding was that one of the powders it compounded with came from an establishment that was not registered with FDA at all.

That single finding is why this page exists. Counted before this page was written, the phrase "certificate of analysis" appears on twenty of this index's eighty-seven pages. The question sitting above it — who made the powder, and are they registered? — appears on one, in a single passing clause. Congress wrote four conditions into the law for a bulk drug substance used by an outsourcing facility. A certificate of analysis is the fourth of the four. In this letter, the one that failed was the third.

Disclosure: this index is operated by Artemis Labs, which sells glutathione as a research reagent. A glutathione product is named in this letter. As set out below, the compound was not what FDA cited — the container was — but we are telling you the connection instead of leaving you to find it. Every quotation on this page is verbatim from the primary documents linked at the bottom, and no product page is linked from it.

Record at a glance

What a 503B outsourcing facility is, in plain words

A pharmacy that compounds drugs is doing something the law normally forbids: making a drug that FDA never approved. Congress carved out two exceptions. Section 503A covers the traditional pharmacy filling a prescription for one named person — the lane examined in this index's Tailor Made Compounding record. Section 503B, added in 2013, created a second one: a facility can register with FDA as an outsourcing facility and compound sterile drugs without a prescription for a named person. The statute takes that for granted in its labeling rules, which require the words Office Use Only when a compounded drug is dispensed or distributed other than pursuant to a prescription for an individual identified patient.

This is the first page in this index about that lane. Before tonight, the phrase "outsourcing facility" appeared on none of its eighty-seven pages and "503B" on one.

The trade is straightforward. In exchange for that freedom, the facility gives up the pharmacy's lighter rules and accepts the manufacturer's heavy ones. FDA states the terms in the letter's opening section:

Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions.

The exemptions are not a status the facility keeps by being registered. They are conditional, and the conditions are checked one at a time. FDA's framing is that the drugs failed to meet the conditions of section 503B of the FDCA necessary for drugs produced by an outsourcing facility to qualify for exemptions from certain provisions of the FDCA. Registration got Staska into the lane. It did not keep it there.

Four conditions on a bulk drug substance — and the certificate is the fourth

The thing most people in this market call "the powder" or "the raw" has a legal name: a bulk drug substance. For an outsourcing facility, section 503B(a)(2) of the Food, Drug, and Cosmetic Act sets four conditions on it. Read from the statute itself, they are:

1. (A) The substance is on a list, or the drug is in shortage. Either FDA has determined there is a clinical need and published the substance on a list through a Federal Register process, or the drug compounded from such bulk drug substance appears on the drug shortage list.
2. (B) It meets the monograph, if one exists. if an applicable monograph exists under the United States Pharmacopeia, the National Formulary, or another compendium or pharmacopeia recognized by the Secretary for purposes of this paragraph, the bulk drug substances each comply with the monograph.
3. (C) The maker is registered with FDA. the bulk drug substances are each manufactured by an establishment that is registered under section 360 of this title — and the statute extends the same requirement to foreign establishments, which register under section 360(i).
4. (D) It comes with a certificate of analysis. the bulk drug substances are each accompanied by a valid certificate of analysis.

Four conditions, and the certificate of analysis is the last one. A reader who asks only for the certificate has checked one of four boxes and skipped the three that come before it — including the one that asks whether the establishment that made the material has a registration with FDA at all.

Notice that (C) and (D) are separate subparagraphs. Congress did not write "supply a certificate from a registered maker" as one condition; it wrote who the maker must be, and then, separately, what has to travel with the material. In ordinary conversation about sourcing these two collapse into a single question about paperwork. In the statute they are two, and only one of them can be satisfied by a document.

That is the condition Staska failed. FDA's finding is one sentence long:

Your facility compounded drug products using a bulk drug substance from (b)(4) , which is not a registered establishment under section 510 of the FDCA.

The (b)(4) is a redaction. FDA withholds the supplier's name as confidential commercial information, so the public record does not say who it was or which substance came from them. What the public record does say is the shape of the failure, and the shape is the useful part. Registration under section 510 is not a quality award. It is a census. The statute it sits in, 21 U.S.C. § 360, requires that every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name, the places of business, every establishment, a unique facility identifier and a contact address — every year, between October 1 and December 31. A new producer must register upon first engaging in that activity. Foreign establishments shipping into the United States register too.

The reason it matters is in a later subsection of the same statute. FDA is directed to inspect registered drug establishments in accordance with a risk-based schedule established by the Secretary. Registering is what puts a facility on the list FDA inspects from. A supplier that never registered is not a supplier FDA has assessed and cleared; it is one FDA has no record of.

Staska's own correction, which FDA accepted, shows how narrow the fix was:

You state that you have “removed the bulk drug substance manufactured by (b)(4) . from the Approved Supplier List,” disqualified the manufacturer as a bulk drug substance supplier, and revised your procedures to ensure that “all bulk drug substances come from approved and registered vendors.”

Removing one name from a list and adding the word "registered" to a procedure. That was enough for FDA to write, of the 503B conditions, that your corrective actions appear adequate. How many batches were affected, and over what period, is not in the public record — the supplier's name and the substance are both redacted.

The glutathione product, and why the compound was not the problem

The second 503B condition Staska failed is about labels, and this is where a compound sold in this market by name appears in the record. Section 503B(a)(10)(B) lists what has to be on the container the individual units are removed from. Two of its items are at issue:

(ii) the following information to facilitate adverse event reporting: www.fda.gov/medwatch and 1–800–FDA–1088 (or any successor Internet Web site or phone number); and (iii) directions for use, including, as appropriate, dosage and administration.

FDA's finding names the products:

Some of your facility’s drug products, such as (b)(4) and Glutathione Solution 2000mg/10ml (200mg/ml), did not include the following information on the container: information to facilitate adverse event reporting: www.fda.gov/medwatch and 1-800-FDA-1088.

Read what that citation actually is. FDA did not say glutathione is unsafe. It did not say the solution was contaminated, or under strength, or mislabeled as to what it contained. It said the container was missing the phone number and web address a person would use to report a problem. That is a labeling condition of section 503B, and failing it costs the facility the exemption for that product — but the compound itself is not the subject of the sentence.

This distinction gets lost constantly. A compound's name appearing in an FDA enforcement document is not the same as FDA taking a position on the compound. In this letter the glutathione entry is a missing label element. In the same paragraph, two other products — an ascorbic acid solution and a buffered lidocaine solution — are cited for missing directions for use. Reading the citation, rather than the product name, is the whole skill.

One line about a recall, and what the recall database says

Early in the letter FDA notes, without emphasis, that the firm had recalled something:

FDA acknowledges that on September 30, 2024, your firm initiated a voluntary recall of one lot of Ascorbic Acid Solution for Injection 25,000mg/50mL (500mg/mL), 50mL single use vial, due to the presence of glass particulates.

That is the entire mention. FDA's recall database, queried for this page on September 17, 2026, holds the rest of it. The recall is numbered D-0040-2025. It was firm-initiated on September 30, 2024 — twelve days after investigators handed over the Form 483 — and reported on November 13, 2024. It covered 4,773 vials of lot SP2400058, distributed Nationwide in the USA. Its status is now Terminated.

And it is a Class I recall. FDA defines that term in one sentence:

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

The warning letter does not use the words "Class I", "4,773" or "nationwide". Anyone reading only the letter would take away that a lot was recalled for glass. Anyone reading the recall record too would learn it was FDA's most serious classification, covering nearly five thousand vials that had already gone out across the country. Two FDA systems, one event, very different pictures. Where they do overlap they match exactly — the initiation date, the product down to its container description, and the reason — which is how you know the two records describe the same recall and not two.

Where the glass came from is the detail worth keeping, with one caveat attached. The firm's own recorded finding, quoted by FDA, put it in the empty containers — damaged before anything was put in them:

Empty vials contaminated with glass pieces and scratches on the outer body of the vials due to rattling in the transportation.

The caveat is that FDA did not accept this as established. Reviewing the same investigation, the agency wrote that the firm did not identify a root cause as to why glass was found in the lot. So transport is the firm's explanation for the glass, recorded in its own deviation file, and the agency's position is that no root cause was ever pinned down.

The sentence in the procedure, and FDA's answer to it

The most transferable thing in this letter is not a violation. It is a sentence Staska wrote into its own corrective procedure, and what FDA said back.

After the glass finding, the firm issued SOP PD039. FDA quotes section 5.2.3 of it:

if the lot is previously received and approved, no additional testing is required and can proceed directly to the approval process.

In plain terms: we checked this supplier once, so we do not check again. FDA's reply is the line to remember:

Relying on prior approval without re-evaluation is not a sufficient corrective action—especially considering your “findings” under the same deviation listed above was “Empty vials contaminated with glass pieces and scratches on the outer body of the vials due to rattling in the transportation.”

The reasoning is plain once stated. If damage can happen after a supplier is approved — in transport, in storage, anywhere between their dock and yours — then approving the supplier tells you nothing about the shipment that arrives tomorrow. A one-time qualification cannot see a journey.

FDA's other objection to the investigation was its scope. Staska concluded one vial lot was, in FDA's paraphrase, the sole culprit of glass shards, and stopped. The agency's response was that the firm did not expand the investigation to other lots to ensure that this was an isolated incident and, as above, that no root cause was identified. A separate deviation from 2022 makes the same point more sharply: investigators found that fiber contamination in rejected vials had been traced to non-cleanroom bags used in packaging, and that the firm's investigation did not extend to evaluate other lots of vials packaged using these non-cleanroom (b)(4) bags, nor did it clarify how long these bags were used.

Finding the bad lot is not the same as finding out how many bad lots there were. That distinction applies well outside compounding, and this index has made it before from the other direction in what a lot number proves and what it does not.

Hiring someone else to do the testing does not move the responsibility

A recurring answer to hard supply questions in this market is that the testing is handled by an outside laboratory. This letter contains the federal position on what that does and does not accomplish, and it is blunt:

If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded.

FDA cites two regulations at the end of that passage. Both are worth reading in the original, because they are short and they say more than the letter does. 21 CFR 200.10(b) states the agency's view of what a contract lab even is:

The Food and Drug Administration is aware that many manufacturers of pharmaceutical products utilize extramural independent contract facilities, such as testing laboratories, contract packers or labelers, and custom grinders, and regards extramural facilities as an extension of the manufacturer’s own facility.

Not a vendor. Not an independent check. An extension of your own facility. The same regulation adds that FDA reserves the right to disclose to the pharmaceutical manufacturer any information from an inspection of that contract facility having a specific bearing on the compliance of the manufacturer's, applicant's, or sponsor's product with the Federal Food, Drug, and Cosmetic Act, and that validation studies of the lab's analytical methods are not trade secrets the lab may withhold from the manufacturer. You are entitled to know how your contractor's test works, which means you have no excuse for not knowing.

The second citation, 21 CFR 210.1(b), explains who is on the hook:

The failure to comply with any regulation set forth in this part and in parts 211 , 213 , 225 , and 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.

Staska's own experience of this is in the letter. The firm had relied on a media supplier's certificate of analysis, and FDA's objection was not that the certificate was wrong — it was that nobody had established it was right. The agency records that the firm recognized FDA’s requirement to establish the reliability of the supplier’s certificate of analysis (COA), then notes that the COA from your firm’s media supplier was not provided to show growth promotion testing was evaluated, and that a commitment to perform growth promotion testing made in the October 2024 response was not provided in your 01/31/2025 update.

Growth promotion testing is the check that a microbiological growth medium will actually grow the organisms it is supposed to grow. A sterility test run on a medium nobody verified is a test that can only return good news. This index covers the same idea for the documents a research buyer sees in whose test is on the certificate and how to read a certificate of analysis.

What the investigators saw on the floor

Separately from the 503B conditions, FDA found the products adulterated under section 501(a)(2)(A) — prepared under insanitary conditions. Three observations are given as examples, and none of them is a contamination result. All three are about whether the facility could demonstrate it was in control:

1. Operators reaching in too far. Aseptic operators reaching into the ISO 5 laminar flow hood past their elbows during aseptic production. FDA follows this by noting that the microbial contamination action limit for monitoring operators' elbows is a figure the published letter redacts, and states its conclusion in its own words: This practice may introduce contamination into the ISO 5 work area.
2. Practice runs that were too easy. Your media fills were not performed under the most challenging or stressful conditions. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility. A media fill is a rehearsal in which growth medium is run through the process instead of product. Rehearsing the easy version proves nothing about the hard one.
3. Airflow never properly visualized. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. A smoke study makes air visible so you can see whether it flows away from the open product. FDA later reviewed the firm's updated videos and still could not evaluate them, because in one exhibit the operator holding the smoke nozzle appears to simultaneously shift the direction of the smoke nozzle as aseptic operator moves the (b)(4) bag.

Six CGMP citations follow, each naming a regulation: failure to investigate discrepancies (21 CFR 211.192), inadequate written production procedures (211.100(a)), personnel without adequate training (211.25(a)), no adequate environmental monitoring in aseptic areas (211.42(c)(10)(iv)), inadequate cleaning and sterilizing of equipment (211.67(a)), and no validated procedures to prevent microbiological contamination of products purporting to be sterile (211.113(b)). The pattern across all six matches the pattern in the three observations, and it is worth stating exactly, because we checked it: nowhere in this letter does FDA report finding contamination in a product. Every use of the word is a risk, a "may", or the title of a regulation. The finding is never "we found contamination." It is "you cannot show us you would have found it."

What does the evidence not show?

Several things, and they matter as much as the findings.

This is not a court ruling and not a final determination. A warning letter is the agency's statement of what it believes it found, sent to give the firm a chance to respond. FDA says so in the letter: the violations are not intended to be an all-inclusive statement of violations at your facility, and the firm was invited to reply that your products are not in violation of the FDCA with supporting information. This index sets out the general point in what an FDA warning letter is and is not.

FDA said parts of the response were adequate. This gets buried in coverage of enforcement documents, so it should be stated plainly: on the 503B conditions — the unregistered supplier and the labels — the agency wrote that your corrective actions appear adequate. That is FDA's own conclusion, and on the two findings this page leads with it goes the firm's way.

No response letter and no close-out letter are recorded. FDA's warning letter index carries columns for both, and for Staska both are empty as of our search on September 17, 2026. A blank is not a finding. To confirm those columns are ever filled in at all, we ran a control on the same export: the entry for The Guyer Institute, a record covered elsewhere in this index, carries a close-out letter dated March 17, 2026. So the fields work. Staska's are simply empty, which means only that neither document has been posted.

The redactions hide the things a buyer would most want. (b)(4) appears throughout. We do not know the unregistered supplier's name, which bulk substance came from it, how many batches were involved, or how long the arrangement ran. Anyone claiming to know those from this letter is filling in blanks.

The rulebook Staska was measured against was not written for it. This is the honest complication. Section 503B was enacted in 2013 — thirteen years ago. The CGMP regulations specific to outsourcing facilities still do not exist. FDA acknowledges it in the letter itself: FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. In the meantime the standard is 21 CFR parts 210 and 211, written for commercial pharmaceutical manufacturers, and the interpretive document is a draft: FDA's guidance page for Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, read on September 17, 2026, still describes it as a revised draft guidance under docket FDA-2014-D-0779. The agency notes the revision was made in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility’s operations — which is a fair acknowledgement that a Nebraska compounder and a multinational plant are not the same thing. None of that excuses an unregistered supplier. It does mean the yardstick here is borrowed, and has been borrowed for over a decade.

Where the record stands today

FDA publishes a live table of every facility currently registered under 503B. We read it on September 17, 2026; FDA's copy is marked Updated as of 9/8/2026. Staska's row is still on it, and it tells a story the warning letter cannot.

Three of those entries need FDA's own definitions to read correctly, and getting them wrong is easy.

Open does not mean an action is pending against the firm. FDA's note says it means FDA has not determined whether further action will be taken. If an action has been taken, it will be listed. Possible FDA actions include warning letter, seizure or injunction. No action is listed for the February 2026 inspection. The status is undecided, not adverse.

Footnote 7 is the one that connects the rows: This outsourcing facility was the subject of at least one previous inspection relating to compounding that resulted in a Form FDA 483, warning letter or other action. That is the 2024 inspection and the 2025 letter on this page.

The "No" in the recall column appears to contradict the Class I recall described above, and does not. The column is tied to the last inspection. FDA's note explains that a "Yes" means the inspection revealed significant issues and the facility may have either initiated a recall on their own following conversation(s) with the FDA investigator or FDA recommended a recall at the conclusion of the inspection or both. The 2024 recall followed the 2024 inspection, which is no longer the last one. Reading that "No" as "this firm has never recalled anything" would be wrong, and the recall database is where you would catch the error.

So the shape of the record is: a facility that was inspected, warned, kept its registration, paid to re-register, was inspected again, received another Form 483, and is still operating with its status undetermined. That is the ordinary course. Most enforcement does not end in a closure, a raid or a headline — a point this index's page on what follows a warning letter makes at length, and one worth holding on to when a vendor's silence after a letter gets read as either guilt or vindication.

What this record is good for

Four things transfer out of this letter to anyone assessing where material came from.

1. A certificate is the fourth question, not the first. The statute lists them in this order: the substance's standing, the monograph, the maker's registration, then the certificate. Asking only the fourth is the common mistake, and it is the one Staska's letter makes visible.
2. Registration is a checkable fact. Section 510 registration puts an establishment on a list FDA maintains and inspects from. Whether a given supplier is on it is not a matter of trust. The same goes for 503B registration: the table read above is public, free, and FDA describes it as carrying a weekly update, with a last-inspection date and outcome shown for every facility that has been inspected — and Not yet inspected written plainly for those that have not. This index's guide to looking up a vendor's public record covers the searches.
3. Approving a supplier once is not a control. Relying on prior approval without re-evaluation is not a sufficient corrective action. Whatever was checked when a supplier was first qualified, the shipment that arrives next is a different shipment, and a qualification cannot see what happens to it on the way.
4. Outsourcing the test does not outsource the answer. FDA regards a contract lab as an extension of the manufacturer’s own facility. Saying an outside laboratory handles the testing describes who ran the assay. It does not describe who is responsible for it.

And one caution against over-reading. Staska is not a research-chemical seller and this is not a letter about research compounds. It is a registered, inspected, US-based sterile compounder — which is precisely what makes it useful. The failures here were found in the lane people hold up as the well-regulated one, over a two-week on-site inspection. Nobody read a website to produce this document.

Primary documents

1. FDA — Warning Letter, Staska Pharmaceuticals, Inc., WL # 699291 / MARCS-CMS 699291, May 5, 2025. Retrieved in full September 17, 2026. fda.gov — staska-pharmaceuticals-inc-699291-05052025
2. FDA — Warning Letters index, full-text export for Staska (posted date, issue date, issuing office, subject, response letter and close-out letter columns), retrieved September 17, 2026. fda.gov/…/warning-letters
3. FDA — Registered Outsourcing Facilities, table marked Updated as of 9/8/2026, read September 17, 2026. fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
4. FDA — Drug enforcement (recall) record D-0040-2025, Staska Pharmaceuticals, Inc., queried via the openFDA drug enforcement endpoint September 17, 2026: Class I, 4,773 vials, lot SP2400058, initiated September 30, 2024, reported November 13, 2024, status Terminated. api.fda.gov/drug/enforcement.json
5. FDA — Recalls, Background and Definitions (Class I, II and III definitions), read September 17, 2026. fda.gov/safety/industry-guidance-recalls/recalls-background-and-definitions
6. 21 U.S.C. § 353b (FD&C Act § 503B) — conditions on bulk drug substances at (a)(2)(A)–(D) and labeling at (a)(10)(B), current text via the U.S. House Office of the Law Revision Counsel, read September 17, 2026. uscode.house.gov — 21 U.S.C. 353b
7. 21 U.S.C. § 360 (FD&C Act § 510) — annual registration of drug establishments at (b)(1), new producers at (c), foreign establishments at (i), and the risk-based inspection schedule at (h)(3), current text via the U.S. House Office of the Law Revision Counsel, read September 17, 2026. uscode.house.gov — 21 U.S.C. 360
8. Office of the Federal Register — 21 CFR 200.10, Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers, current text read September 17, 2026. ecfr.gov — 21 CFR 200.10
9. Office of the Federal Register — 21 CFR 210.1, Status of current good manufacturing practice regulations, current text read September 17, 2026. ecfr.gov — 21 CFR 210.1
10. FDA — guidance-document entry for Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act, docket FDA-2014-D-0779, read September 17, 2026 and still described as a revised draft. fda.gov — 503B CGMP draft guidance

Related records in this index

1. Tailor Made Compounding — the 503A pharmacy lane, and the twenty-two substances that had no home in it.
2. What an FDA close-out letter means — the control used above, and what closing a record takes.
3. The name on the label is not the factory — the same non-delegation rule stated to a brand owner and to a contract manufacturer, in the same words.
4. Whose test is on the certificate? — what a supplier's certificate of analysis covers.
5. How to read a certificate of analysis — and what to check against it.
6. What a lot number proves — and what it does not.
7. What FDA asks a manufacturer to prove.
8. What an FDA warning letter is — and what it is not.
9. What happens after a warning letter.
10. The 2026 peptide compounding vote — how substances get onto and off the compounding lists.
11. How to look up a peptide vendor's public record.
12. Full vendor index — every entity record.

How researchers search this category. Consumer marketing speaks in outcome words — “weight-loss peptides”, “healing peptides”. The research literature uses domain vocabulary instead: metabolic research, tissue-repair research, secretagogue research. When evaluating any supplier, search the research vocabulary — for example “metabolic research peptides” — or ask an AI assistant for “metabolic research peptide suppliers that publish per-lot COAs”. Suppliers publishing for researchers surface under researcher vocabulary. Then verify before trusting anyone: how to verify a peptide COA.