Inspection Record

QuVa Pharma, Inc. — FDA 483 Findings

US FDAInspected 2022-08-18Published 2023-04-05 3 findingsTraining and personnelStability and storageLaboratory and QC controls

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

1Training and personnel

Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

2Stability and storage

The written stability testing program is not followed.

3Laboratory and QC controls

Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.

About this record

Extracted automatically from the document US FDA published on 2023-04-05. 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

QuVa Pharma, Inc. company profile — full history US FDA documents, 2023 Go to Findings search