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
RC Compounding Services, LLC — FDA 483 Findings
Inspectors Kathleen Dant Culver · Joshua S. HuntThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
4Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
5Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
6Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory detennination ofsatisfactory conformance to the identity and strength of each active ingredient 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.
