1Other quality system
The written procedures and records for retaining samples were inadequate.
Inspection Record
Ortho Biologics LLC — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.
3Other quality system
The recorded information or details were inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The handling of standard operating procedures for good manufacturing practices was inadequate.
4Equipment and facility
Materials, bulk containers, major items of equipment, and/or the rooms were not properly identified.
5Laboratory and QC controls
The examination and/or approval of fabrication, packaging, labelling, testing, storage, and/or the transportation method and procedures by the person in charge of the quality control department before implementation was inadequate.
6Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-19. 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.
