1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
Sharon Bio-Medicine Limited — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
3Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
4Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Cleaning validation
The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The availability, implementation, and/or quality of the written sanitation program was inadequate.
6Other quality system
The electronic system was not validated for its intended use.
7Other quality system
The evidence required to demonstrate compliance with finished product specifications was inadequate.
8Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
9Other quality system
The receipt, preparation, and/or handling of reagents and culture media was inadequate.
10Other quality system
Critical production processes were not validated.
11Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
12Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.
13Labeling and packaging
The written agreement for outsourcing fabrication, packaging or labelling, and/or testing activities was inadequate.
14Material and supplier control
A reduced retesting program for raw materials was in place without the raw material vendor certification.
15Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
16Quality unit oversight
The annual product quality review procedure was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-13. 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.
