1Other quality system
The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.
Inspection Record
Macopharma Canada Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
The content of the batch certificate 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 training of personnel before new or revised standard operating procedures were implemented was inadequate.
4Other quality system
The recorded information or details were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.
5Other quality system
The written specifications were inadequate. Tests were not performed according to approved specifications.
6Other quality system
The controls put in place for electronic signatures were inadequate.
7Stability 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. The procedures in place were inadequate for the storage, transportation, records, and/or testing of purchased media.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-03-22. 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.
