1Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
Inspection Record
Erfa Canada 2012 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.
3Complaint and recall handling
The written procedures for recalls were inadequate.
4Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions. Documents were not available in one of the official languages.
5Quality unit oversight
The annual product quality review procedure was inadequate.
6Equipment and facility
The maintenance of personnel records was inadequate.
7Equipment 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.
8Labeling 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).
9Other quality system
The implementation of a self-inspection program was inadequate.
10Other quality system
Complete testing was not performed according to the requirements.
11Laboratory and QC controls
The person responsible for making decisions about quality control requirements did not have adequate knowledge of on-site operations to fulfill the responsibilities of this position. The quality control department's access to adequate facilities, trained personnel, materials, and/or equipment was inadequate to fulfill its duties and responsibilities.
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.
13Other quality system
The importer and/or the distributor's compliance with the current master production documents and/or the marketing authorization was inadequate.
14Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
15Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
16Complaint and recall handling
The quality control department's handling of complaints and/or information received about drug quality was inadequate.
17Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
18Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-16. 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.
