1Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
Inspection Record
Olds Softgels Ltd. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
3Complaint and recall handling
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The quality control department's handling of complaints and/or information received about drug quality was inadequate.
4Stability and storage
The temperature and/or humidity control was inadequate.
5Material and supplier control
The sampling plan for raw materials was inadequate.
6Equipment and facility
The preventative maintenance and repair of the equipment was inadequate.
7Stability and storage
The frequency of stability testing of a drug did not comply with the marketing authorization.
8Other quality system
The monitoring procedures for microbial and/or environmental conditions were inadequate.
9Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-21. 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.
