1Complaint and recall handling
The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.
Inspection Record
Alera Skin Care Products 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 handling of standard operating procedures for good manufacturing practices was inadequate.
3Other quality system
The written procedures and records for retaining samples were inadequate.
4Stability 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 temperature and/or humidity control was inadequate.
5Other quality system
The implementation of a self-inspection program was inadequate. The written self-inspection procedure was inadequate.
6Quality unit oversight
The annual product quality review procedure was inadequate.
7Laboratory and QC controls
The duties of the individual in charge of the quality control department were delegated to an unqualified individual.
8Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
9Complaint and recall handling
The written procedures for recalls were inadequate.
10Laboratory 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.
11Equipment and facility
The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate. The job descriptions for personnel, the authority given to personnel, and/or the delegation of duties was inadequate and/or undocumented.
About this record
Extracted automatically from the document of the Health Canada inspection on 2023-06-05. 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.
