1Training and personnel
Employees engaged in the manufacture, processing and packing of a drug product lack the training required to perform their assigned functions.
Inspection Record
QuVa Pharma, Inc. — FDA 483 Findings
Inspectors Logan T WilliamsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The accuracy specificity and reproducibility of test methods have not been established.
3Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been akeady distributed.
4Laboratory and QC controls
The statistical quality control criteria fail to include appropriate rejection levels.
5Other quality system
Written procedures for sanitation are not followed.
About this record
Extracted automatically from the document US FDA published on 2025-05-07. 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.
