1Validation and qualification
The qualification and/or verification of utilities and/or support systems was inadequate.
Inspection Record
KDC/One Development Corporation Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
The protection of products and/or materials from contamination was inadequate.
3Material and supplier control
The handling of raw materials, products, or packaging materials in keeping with pre-approved written procedures or instructions was inadequate.
4Computer system validation
The creation, maintenance, processing, and/or review of laboratory data was inadequate. The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
5Equipment and facility
The maintenance of records was inadequate.
6Computer system validation
The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate.
7Material and supplier control
The drug fabricator's specifications for raw materials were inadequate.
8Cleaning validation
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
9Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
10Equipment and facility
The preventative maintenance and repair of the equipment was inadequate. The equipment was not set-up, designed, operated, stored, and/or maintained to prevent potential contamination of drugs by other drugs and/or by foreign material.
11Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
12Laboratory and QC controls
The quality control department did not undertake all of the required activities.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-11-14. 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.
