Inspection Record

Staska Pharmaceuticals, Inc — FDA 483 Findings

US FDAInspected 2026-02-20Published 2026-05-08 3 findingsLaboratory and QC controlsDeviation, CAPA, and investigationAseptic processing and sterility assurance

Inspectors Carl A Huffman · Chad W RiceThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

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.

2Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

About this record

Extracted automatically from the document US FDA published on 2026-05-08. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Other records for this company

2025-07-01 · US FDA · 17 findings2024-09-18 · US FDA · 9 findings
Staska Pharmaceuticals, Inc company profile — full history US FDA documents, 2026 Go to Findings search