1Aseptic processing and sterility assurance
The sampling procedure was inadequate for microbiological monitoring in processing areas or aseptic areas.
Inspection Record
Centre C3i Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The raw materials used to fabricate a drug were not tested against the specifications, did not comply with the specifications, and/or were expired. The drug fabricator's specifications for raw materials were inadequate.
3Aseptic processing and sterility assurance
Sterile disinfectants were not used in Grade A and B areas. The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
4Aseptic processing and sterility assurance
The company did not validate all sterilization processes. The validation of aseptic processing was inadequate.
5Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
6Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
7Training and personnel
The health requirements for personnel were not captured in a written procedure.
8Material and supplier control
The suitability of the culture media was not verified. The handling and/or storage of samples was inadequate for raw materials, drugs being processed, bulk drugs, and/or finished products.
9Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
10Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
11Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
12Validation and qualification
The working spaces were inadequate. The qualification and/or verification of utilities and/or support systems was inadequate.
13Other quality system
The master formulas to control the manufacturing process were inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-04-30. 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.
