1Other quality system
The recorded information or details were inadequate. The master production documents were inadequate. Documents were not available in one of the official languages.
Inspection Record
Bayer Inc — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
3Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
4Material and supplier control
The company did not store a sample from each lot or batch of a drug, raw material, and/or an active ingredient under the proper conditions.
5Other quality system
The controls put in place for electronic signatures were inadequate.
6Equipment 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.
7Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Equipment and facility
The maintenance of records was inadequate.
11Equipment and facility
The ongoing training of personnel was inadequate. The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
12Other quality system
The assessment to release finished products was inadequate.
13Complaint and recall handling
The written recall system did not include distribution records that allowed each drug to be traced.
14Equipment and facility
"The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-02-07. 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.
