1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
Inspection Record
Pharmacia & Upjohn Company LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
3Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
4Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
5Equipment and facility
The protection of products and/or materials from contamination was inadequate. Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-20. 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.
