1Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
Inspection Record
Steri-Med Pharma 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.
3Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
4Training and personnel
The ongoing training of personnel was inadequate.
5Stability and storage
For long-term stability studies, the company did not test the drug often enough to establish its retention period.
6Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
7Other quality system
The availability or the content of the authentic certificate of analysis was inadequate.
8Stability and storage
The ongoing stability program for a drug was inadequate.
9Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
10Equipment and facility
The maintenance of detailed plans or specifications was inadequate for each building where drugs are fabricated, packaged, labelled, and/or tested.
11Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
12Contamination control
The drug was fabricated, packaged, labelled, and/or stored in premises that were not designed, constructed, and/or maintained to allow for effective cleaning, sanitary conditions, and/or the prevention of drug contamination.
13Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
14Equipment and facility
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved. Changes to production processes, systems, equipment, materials, and/or suppliers were not validated before they were implemented.
15Other quality system
The recorded information or details were inadequate.
16Aseptic processing and sterility assurance
The monitoring procedures for microbial and/or environmental conditions were inadequate. The validation of aseptic processing was inadequate.
17Aseptic processing and sterility assurance
The company's validation of moist heat sterilization was inadequate. The company's monitoring and documentation of moist heat sterilization cycles was inadequate.
18Material and supplier control
Materials were used after their expiry date or retest date.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-12. 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.
