1Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
Inspection Record
PBG BioPharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
3Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
6Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
7Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
8Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
9Training and personnel
The ongoing training of personnel was inadequate. The training of personnel before new or revised standard operating procedures were implemented was inadequate.
10Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
11Other quality system
The electronic system was not validated for its intended use.
12Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-05-04. 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.
