1Equipment 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.
Inspection Record
PHL Distributions 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.
3Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
4Other quality system
The master production documents were inadequate.
5Laboratory and QC controls
The validation of test methods was inadequate. The written protocol and/or the assessment of the test method transfer was inadequate.
6Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-05-03. 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.
