1Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
Inspection Record
Omega Laboratories Ltd. (now Juno Pharma Canada Inc.) — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Training and personnel
The ongoing training of personnel was inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
5Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media. The expiry date of the prepared culture media was not supported by the growth-promotion testing.
6Other quality system
The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
7Aseptic processing and sterility assurance
The samples taken for sterility testing were not representative of the whole batch.
8Aseptic processing and sterility assurance
The company's cleaning of the premises and the equipment in aseptic areas was inadequate.
9Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
10Equipment and facility
The maintenance of the premises was inadequate.
11Equipment and facility
The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
12Stability and storage
The temperature and/or humidity control was inadequate.
13Aseptic processing and sterility assurance
The portable particle counters were inadequate to classify the airborne particulates in aseptic or clean areas.
14Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-12-07. 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.
