The handling of standard operating procedures for good manufacturing practices was inadequate.
Inspection Record
Apollo Health and Beauty Care — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
The quality agreement outlining the responsibilities for fabricating, packaging or labelling, and/or testing was inadequate.
The ongoing stability program for a drug was inadequate.
The master formulas to control the manufacturing process were inadequate.
The specifications were not in writing and/or approved by the person in charge of the quality control department or the designated alternative. The written specifications were inadequate.
Validation studies were not conducted in keeping with the predefined protocols.
The assessment to release finished products was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-01-25. 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.
