1Deviation, CAPA, and investigation
Investigations into deviations, reports, and/or follow-up actions were inadequate.
Inspection Record
Cryogen Nitrogen Deliveries Ltd. — 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 quality control department's release of packaging materials for use in packaging or labelling was inadequate.
3Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The ongoing training of personnel was inadequate.
4Laboratory and QC controls
The quality control department did not approve, sign, and/or date the good manufacturing practices documents and/or the standard operating procedures.
5Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
6Equipment and facility
The maintenance of evidence was inadequate for manufacturing, packaging, labelling, required testing, storage, and/or distribution, including the respective conditions.
7Other quality system
Lots or batches of finished product were not examined or tested against the specifications before they were fabricated or sold.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-09. 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.
