1Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate.
Inspection Record
Medicago USA Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.
3Stability and storage
The temperature and/or humidity control was inadequate.
4Material and supplier control
The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate.
5Material and supplier control
The protection of products and/or materials from contamination was inadequate.
6Other quality system
The handling of standard operating procedures for good manufacturing practices was inadequate.
7Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
8Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
9Equipment and facility
The establishment and/or the maintenance of a data governance plan was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-06-13. 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.
