1Material and supplier control
The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
Inspection Record
Neopharm Labs Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range. The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility. The process was inadequate for the environmental classification of aseptic or clean areas. The design, equipment, and/or maintenance of the testing laboratory was inadequate.
4Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-22. 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.
