Inspection Record

QuVa Pharma Inc — FDA 483 Findings

US FDAInspected 2026-05-04Published 2026-07-01 3 findingsDeviation, CAPA, and investigationEquipment and facilityAseptic processing and sterility assurance

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Equipment and facility

Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.

3Aseptic processing and sterility assurance

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

About this record

Extracted automatically from the document US FDA published on 2026-07-01. 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

2025-03-04 · US FDA · 5 findings2024-10-28 · US FDA · 4 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, 2026 Go to Findings search