1Documentation and records
Batch production and control records are not prepared for each batch of drug product produced.
Inspection Record
Techni Med, Inc. dba The Compounder — FDA 483 Findings
Inspectors Emilie Kahn · Bryan L McguckinThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
4Contamination control
You produced beta-lactam drugs without providing adequate segregation and cleaning of work surfaces to prevent cross-contamination.
5Stability and storage
Results of stability testing are not used in determining expiration dates.
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.
