1Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.
Inspection Record
Cosmaceutical Research Lab Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling 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).
3Stability and storage
The temperature and/or humidity control was inadequate.
4Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
5Laboratory and QC controls
The design, equipment, and/or maintenance of the testing laboratory was inadequate.
6Stability and storage
The ongoing stability program for a drug was inadequate.
7Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
8Labeling and packaging
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-07-26. 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.
