1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Novocol Pharmaceutical of Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
4Other quality system
The company did not retain large enough samples to allow duplicate testing by the company and Health Canada.
5Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
6Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
7Material and supplier control
The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.
8Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
9Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
10Other quality system
The recorded information or details were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-08. 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.
