1Aseptic processing and sterility assurance
The aseptic process simulation study was not long enough to cover all routine manipulations, normal interventions, and worst case situations.
Inspection Record
Bausch & Lomb Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
3Aseptic processing and sterility assurance
The validation of aseptic processing was inadequate.
4Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.
5Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
6Contamination control
The sanitation programs were not adequately designed to identify and/or reduce the risks of contamination.
7Other quality system
The environmental sampling methods were inadequate.
8Material and supplier control
Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.
9Laboratory and QC controls
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The monitoring procedures for microbial and/or environmental conditions were inadequate.
10Computer system validation
The receipt, preparation, and/or handling of reagents and culture media was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
11Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
12Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
13Equipment and facility
The validation of equipment or the planned maintenance of equipment was inadequate.
14Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
15Stability and storage
The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
16Equipment and facility
The environmental sampling methods were inadequate. The airborne particle monitoring system was inadequate. The company did not design or maintain the premises and equipment to minimize microbial contamination and the number of airborne particles in clean areas.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-12-11. 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.
