1Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
Inspection Record
Pharmascience Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
In areas where aseptic operations were performed, the frequency and the methods of monitoring were inadequate.
3Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The usage logs for the equipment used for significant processing and/or testing operations were inadequate.
4Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
5Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
6Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
7Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
8Other quality system
The recorded information or details were inadequate.
9Material and supplier control
The packaging materials vendor certification program was inadequate.
10Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
11Material and supplier control
An audit report was not available or was inadequate under the raw material vendor certification program.
12Contamination control
The company did not adequately demonstrate that air-flow patterns did not pose a risk of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-12-01. 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.
