1Other quality system
The written clothing standards for each environmental grade were inadequate.
Inspection Record
Pharmascience Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
The company did not adequately monitor the clean areas used for the less critical stages of manufacturing sterile products.
3Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate. The operators'aseptic practices were inadequate to maintain sterility.
4Aseptic processing and sterility assurance
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas. The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
5Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
6Aseptic processing and sterility assurance
The company did not adequately protect sterilized material to prevent re-contamination after sterilization.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-03-21. 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.
