1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
HK Kolmar Canada, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The annual product quality review procedure was inadequate.
3Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Equipment 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.
6Other quality system
The company's monitoring of water testing was inadequate.
7Laboratory and QC controls
The quality control department did not appropriately approve, assess, and/or document the reprocessing and/or reworking of a lot and/or batch. The reworked lot was not included in the ongoing stability program (the testing of drug samples over time).
8Other quality system
Lots or batches of finished product did not comply with the specifications and were made available for further fabrication or sale.
9Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
10Training and personnel
The ongoing training of personnel was inadequate.
11Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
12Equipment 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.
13Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
14Complaint and recall handling
The written procedures for recalls were inadequate.
15Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
16Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
17Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
18Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
19Other quality system
The implementation of a self-inspection program was inadequate.
20Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
21Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
22Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-03-29. 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.
