Inspection Record

QuVa Pharma Inc. — FDA 483 Findings

US FDAInspected 2017-02-08Published 2024-01-17 3 findingsLabeling and packagingAseptic processing and sterility assurance

Inspectors Stephen D Brown · Lisa R JenningsThe inspectors who signed the published document.Inspector lookup

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

Findings

1Labeling and packaging

The labels of your outsourcing facility's drug products are deficient.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

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 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 findings2018-05-30 · US FDA · 4 findings
QuVa Pharma Inc. findings history — including this company's other documents US FDA documents, 2024 Go to Findings search