1Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
Inspection Record
Pro Doc Limitée — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
3Other quality system
The electronic system was not validated for its intended use.
4Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
5Other quality system
The assessment to release finished products was inadequate.
6Stability and storage
The stability program for a drug did not include a minimum of one batch of every strength of the drug for every year the drug was fabricated.
7Equipment and facility
The production areas were not restricted to designated staff only. The handling of rejected materials and products was inadequate. The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate. Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
8Equipment and facility
The maintenance of records was inadequate.
9Quality unit oversight
The annual product quality review procedure was inadequate.
10Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
11Other quality system
Critical production processes were not validated.
12Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
13Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
14Other quality system
The recorded information or details were inadequate.
15Material and supplier control
The packaging materials vendor certification program was inadequate.
16Equipment 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.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-06-14. 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.
