Key facts
| Firm | Staska Pharmaceuticals, Inc |
|---|---|
| FEI / inspection ID | 3017473850 |
| Inspection end date | February 20, 2026 |
| Citation count | 2 |
Citations explained
Observation 1 — There is a failure to thoroughly review any unexplained discrepancy whether or
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, Your procedures do not require investigation when Acceptable Qual.ity Limit (AQL) sampling fails after 100% visual inspection. On July 10, 2025, during visual inspection of Ascorbic Acid Preservative Free Injection batch SP2500050, (batch size: Ill · 4 units), your initial 100% visual inspection rejected 80 critical, 49 major, and 12 minor defects. Subsequent AQL sampling identified 5 major defects, exceeding your acceptance criterion of~ major defects, and the AQL failed. Your Quality Unit approved proceeding to {b)(4) visual inspection wi thout initiating an investigation to determine why the initial 100% visual inspection failed to detect the 5 major defects found during AQL sampling, without documenting the rationale for this decision, and without evaluating whether other batches may be similarly affected. After (b) (41 visual inspection and tightened AQL sampling (which passed), the batch was released. Your procedure PRD07 "V isual.
Observation 2 — Laboratory controls do not include the establishment of scientifically sound and appropriate
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, Your firm lacks adequate controls to ensure the integrity and reliability of analytical data generated by High-Performance Liquid Chromatography (HPLC) systems used for release testing of sterile drug products. EMPLOYEE(S) SlGNATURE DATE I SSUED SEE REVERSE Chad w Rice, Investigator 2/20/2026 OF THIS PAGE Carl A Huffman, Investigator = CtladWRICe r 200'2111256 X 02-20-2026 09:03 PAGE I of4 PAGES
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Staska Pharmaceuticals, Inc’s FDA history
Argus HQ has recorded 1 total FDA action tied to Staska Pharmaceuticals, Inc: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Staska Pharmaceuticals, Inc had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Staska Pharmaceuticals, Inc so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3017473850.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Staska Pharmaceuticals, IncCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). Form 483 Record: Staska Pharmaceuticals, Inc, February 20, 2026 — 2 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-staska-pharmaceuticals-inc-2026-02-20-3017473850
"Form 483 Record: Staska Pharmaceuticals, Inc, February 20, 2026 — 2 Citations." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/483/fda-483-staska-pharmaceuticals-inc-2026-02-20-3017473850.
Argus HQ Research. "Form 483 Record: Staska Pharmaceuticals, Inc, February 20, 2026 — 2 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-staska-pharmaceuticals-inc-2026-02-20-3017473850.
@misc{argushq_argushq_ai_483_fda_483_staska_pharmaceuticals_inc_2026_02_20_3017473850_2026,
title = {Form 483 Record: Staska Pharmaceuticals, Inc, February 20, 2026 — 2 Citations},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-staska-pharmaceuticals-inc-2026-02-20-3017473850},
note = {Accessed: July 15, 2026}
}