Inspection Record

QuVa Pharma Inc — FDA 483 Findings

US FDAInspected 2024-10-28Published 2025-01-16 4 findingsProcess validationComplaint and recall handlingQuality unit oversightAseptic processing and sterility assurance

Inspectors Camerson E MooreThe inspectors who signed the published document.Inspector lookup

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 drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

2Complaint and recall handling

Complaint records are deficient in that they do not include the findings of the investigation.

3Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

4Aseptic processing and sterility assurance

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

About this record

Extracted automatically from the document US FDA published on 2025-01-16. 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

2026-05-04 · US FDA · 3 findings2025-03-04 · US FDA · 5 findings2016-03-12 · US FDA · 4 findings2016-03-12 · US FDA · 5 findings2018-05-30 · US FDA · 4 findings2017-02-08 · US FDA · 3 findings
QuVa Pharma Inc company profile — full history US FDA documents, 2025 Go to Findings search