Inspection Record

QuVa Pharma, Inc. — FDA 483 Findings

US FDAInspected 2018-05-30Published 2024-01-17 4 findingsQuality unit oversightProcess validationAseptic processing and sterility assuranceComplaint and recall handling

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

Findings

1Quality unit oversight

The quality control unit lacks authority to fully investigate en ors that have occuned.

2Process validation

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

3Aseptic processing and sterility assurance

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.

4Complaint and recall handling

Written records of investigation of a drug complaint do not include the findings of the investigation.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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 findings2024-10-28 · US FDA · 4 findings2016-03-12 · US FDA · 4 findings2016-03-12 · US FDA · 5 findings2017-02-08 · US FDA · 3 findings
QuVa Pharma, Inc. company profile — full history US FDA documents, 2024 Go to Findings search