1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
PBR Laboratories Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
3Other quality system
The purified water system was inadequate with the potential for water not meeting the appropriate requirements for chemical and microbial purity.
4Other quality system
The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.
5Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
6Stability and storage
The temperature and/or humidity control was inadequate.
7Other quality system
The expiry date of the prepared culture media was not supported by the growth-promotion testing.
8Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
9Aseptic processing and sterility assurance
The process was inadequate for the environmental classification of aseptic or clean areas. In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
10Aseptic processing and sterility assurance
The written sanitation program for clean areas was inadequate. Sterile disinfectants were not used in Grade A and B areas. The written clothing standards for each environmental grade were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-08-08. 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.
