The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
AMPAC Fine Chemicals Virginia, LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
The design, location, and/or maintenance of the equipment was inadequate for allowing the equipment to serve its intended purpose
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-02-07. 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.
