1Other quality system
The sampling, testing, and/or specifications for total microbial count were inadequate.
Inspection Record
Delta Pharma 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 maintenance of the premises was inadequate.
3Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
4Training and personnel
The education, experience, and/or oversight of the individual in charge of the manufacturing department was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
5Labeling 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).
6Equipment and facility
The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose The design, construction, operation, and/or location of the equipment was inadequate for preventing contamination of the drug.
7Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
8Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
9Computer system validation
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. The establishment and/or the maintenance of a data governance plan was inadequate.
10Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
11Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
12Deviation, CAPA, and investigation
The evaluation was inadequate for cases where there was a deviation from the norm and/or where products were on the borderline of the acceptable range.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-31. 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.
