1Other quality system
The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The electronic system was not validated for its intended use.
Inspection Record
McCaughey Consumer Products Management, Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.
3Stability and storage
The ongoing stability program for a drug was inadequate.
4Training and personnel
The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented. The training of personnel before new or revised standard operating procedures were implemented was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-06. 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.
