Inspection Record
Inspectors Jamie L. DionThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
Test procedures relative to appropriate laboratory testing for sterility are not written.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
Clothing of personnel engaged in the processing and packing of drug products is not appropriate for the duties they perform.
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
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.
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