1Stability and storage
The ongoing stability program for a drug was inadequate.
Inspection Record
J.L. Freeman S.E.C. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
3Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
4Equipment 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.
5Other quality system
Documents were not available on the premises.
6Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Complaint and recall handling
The written procedures for recalls were inadequate.
8Training and personnel
The training of personnel before new or revised standard operating procedures were implemented was inadequate.
9Other quality system
The recorded information or details were inadequate.
10Complaint 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 2024-02-13. 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.
