Inspection Record

PQ Pharmacy LLC — FDA 483 Findings

US FDAInspected 2025-04-04Published 2025-05-07 4 findingsProcess validationAseptic processing and sterility assuranceDeviation, CAPA, and investigation

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

Findings

1Process validation

Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess.

2Aseptic processing and sterility assurance

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

3Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

4Deviation, CAPA, and investigation

Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

About this record

Extracted automatically from the document US FDA published on 2025-05-07. 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

2025-12-02 · US FDA · 13 findings2022-10-27 · US FDA · 6 findings
PQ Pharmacy LLC findings history — including this company's other documents US FDA documents, 2025 Go to Findings search