1Other quality system
The implementation of a self-inspection program was inadequate. The written self-inspection procedure was inadequate.
Inspection Record
Almat Pharmachem Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The ongoing stability program for a drug was inadequate.
3Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
4Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
5Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Other quality system
The confirmatory tests conducted on samples before or after they were received in Canada were inadequate. The evidence required to demonstrate compliance with finished product specifications was inadequate. The assessment to release finished products was inadequate.
8Quality unit oversight
The annual product quality review procedure was inadequate.
9Equipment 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.
10Labeling 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).
11Laboratory and QC controls
The quality control department did not undertake all of the required activities.
12Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-05-31. 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.
