1Other quality system
The electronic system was not validated for its intended use.
Inspection Record
Delpharm Boucherville Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
3Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
4Quality unit oversight
The annual product quality review procedure was inadequate.
5Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
6Equipment and facility
The maintenance of records was inadequate.
7Aseptic processing and sterility assurance
The portable particle counters were inadequate to classify the airborne particulates in aseptic or clean areas.
8Other quality system
No records were available for reprocessed and/or reworked lots.
9Aseptic processing and sterility assurance
The company's investigations of microbial contamination in critical areas were inadequate. The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
10Material and supplier control
An audit report was not available or was inadequate under the raw material vendor certification program.
11Material and supplier control
The testing or examination of packaging materials was inadequate on a sample received on the premises by a person that packages the drugs.
12Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
13Material and supplier control
The sampling plan for raw materials was inadequate.
14Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
15Stability and storage
Reworked or reprocessed drug lots were not included in the ongoing stability program. The ongoing stability program for a drug was inadequate.
16Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-08. 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.
