Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Inspection Record
QuVa Pharma, Inc. — FDA 483 Findings
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
The written stability testing program is not followed.
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.
