1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Delmar Chemicals Inc./Les Produits Chimiques Delmar 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 availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
4Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
5Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired.
6Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
7Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Complaint and recall handling
The quality control department did not ensure a thorough investigation and/or evaluation of complaints concerning potentially defective products.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-09-26. 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.
