1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
IntelliPharmaCeutics Corp. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
5Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
6Training and personnel
The ongoing training of personnel was inadequate.
7Complaint and recall handling
The written procedures for recalls were inadequate.
8Other quality system
The implementation of a self-inspection program was inadequate.
9Other quality system
The master production documents were inadequate.
10Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-05-31. 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.
