1Other quality system
The working spaces were inadequate.
Inspection Record
Emergent Manufacturing Operations Baltimore, LLC — 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 creation, maintenance, processing, and/or review of laboratory data was inadequate.
3Other quality system
Senior management's ability to determine and/or provide adequate and/or appropriate resources to implement, maintain and/or improve the effectiveness of the quality management system was inadequate.
4Laboratory and QC controls
The validation of test methods was inadequate.
5Equipment and facility
The maintenance of records was inadequate.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Equipment and facility
Evaluation of production processes, equipment, and/or materials was inadequate.
8Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
9Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
10Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
11Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
About this record
Extracted automatically from the document of the Health Canada inspection on 2021-10-25. 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.
