1Material and supplier control
The availability and/or the content of the written agreement between the raw material vendor and the drug fabricator was inadequate.
Inspection Record
DeLaval 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 guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug. The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
3Laboratory and QC controls
The validation and/or the documentation of test methods was inadequate.
4Other quality system
The electronic system was not validated for its intended use.
5Complaint and recall handling
The written procedures for recalls were inadequate.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Equipment and facility
The maintenance of records was inadequate.
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.
12Labeling and packaging
The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
13Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
14Other quality system
The controls put in place for electronic signatures were inadequate.
15Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
16Training and personnel
The ongoing training of personnel was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-24. 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.
