1Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
Inspection Record
Alk-Abello Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The environmental sampling methods were inadequate.
3Other quality system
The company's visual inspection of filled containers was inadequate.
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
6Laboratory and QC controls
The validation of test methods was inadequate.
7Aseptic processing and sterility assurance
The company did not perform an aseptic process simulation study to demonstrate the validity of the aseptic filling operations.
8Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
9Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
10Other quality system
A document was not issued for each vendor verifying the vendor meets the criteria for certification.
11Deviation, 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.
12Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-07-08. 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.
