1Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Inspection Record
Brown’s Compounding Center, Inc. — FDA 483 Findings
Inspectors Tomika L. BivensThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
Written production nlld process control procedures are not followed in the execution of production and process control functions.
3Process validation
There are no written procedures for production and process controls designed to assure that the drug products ha ve the idcntily, strength, quality, and purity they purport or arc represented to possess.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purpot1ing to be sterile are not established.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory detennination ofsatisfactory conformance to the final specifications prior to release.
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.
