1Other quality system
The written self-inspection procedure was inadequate.
Inspection Record
Pancap Pharma Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
3Other quality system
The recorded information or details were inadequate.
4Material and supplier control
The premises were not constructed and/or maintained to allow cleaning and/or prevent the accumulation of foreign material.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
7Other quality system
The availability, implementation, and/or quality of the written sanitation program was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Other quality system
Measuring devices were not regularly checked for accuracy and precision.
10Equipment and facility
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
11Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
12Training and personnel
The effectiveness of the training was not assessed by the firm. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
13Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-01-24. 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.
