1Contamination control
The premises were not designed, constructed, operated, and/or maintained to prevent contamination.
Inspection Record
Hospira 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 validation of test methods was inadequate.
3Aseptic processing and sterility assurance
The operators'aseptic practices were inadequate to maintain sterility.
4Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
5Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
6Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
7Other quality system
The "Water for Injection" was not produced, stored or distributed to prevent microbial growth.
8Other quality system
The written sanitation program for clean areas was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-11-08. 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.
