1Stability 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.
Inspection Record
West Penetone 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 electronic system was not validated for its intended use.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Material and supplier control
The sampling plan for raw materials was inadequate. The recorded information or details were inadequate.
5Stability and storage
The design of the drug stability study was inadequate and/or not justified with a documented rationale.
6Training and personnel
The ongoing training of personnel was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
7Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
8Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
9Stability and storage
The temperature and/or humidity control was inadequate.
10Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
11Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
12Complaint and recall handling
The written procedures for recalls were inadequate.
13Contamination control
The drug was fabricated, packaged, labelled, and/or stored in premises that were not designed, constructed, and/or maintained to allow for effective cleaning, sanitary conditions, and/or the prevention of drug contamination. The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
14Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
15Other quality system
The controls put in place for electronic signatures were inadequate.
16Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations
17Other quality system
The implementation of a self-inspection program was inadequate.
18Equipment and facility
The maintenance of records was inadequate.
19Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
20Equipment and facility
The maintenance and/or monitoring of the ventilation system's air quality was inadequate. The qualification and/or verification of utilities and/or support systems was inadequate. The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-01-25. 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.
