Inspection Record
Inspectors Jessica L. Pressley · Carla A. NorrisThe 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 satisfactmy conformance to the final specifications and identity and strength of each active ingredient prior to release.
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties the y perform.
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing o f drug products.
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Each batch of drug product purporting to be sterile is not laboratoiy tested to determine conformance to such requirements.
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particuJate air filters under positive pressure.
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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