1Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laborator y testing.
Inspection Record
The Compounding Shop, Inc. — FDA 483 Findings
Inspectors Nicole E. Knowlton · Michael H. TollonThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
3Complaint and recall handling
Complaint records are deficient in that they do not include the findings ofthe investigation and follow-up.
4Deviation, CAPA, and investigation
There is a fuilure 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 already distributed.
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.
