1Other quality system
The written procedures and records for retaining samples were inadequate.
Inspection Record
2253500 Alberta Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material 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.
3Complaint and recall handling
The written procedures for recalls were inadequate.
4Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
5Validation and qualification
Validation studies were not conducted in keeping with the predefined protocols. The master formulas to control the manufacturing process were inadequate.
6Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Other quality system
The master production documents were inadequate. The recorded information or details were inadequate.
9Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
10Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
11Other quality system
The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-05. 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.
