1Laboratory and QC controls
The quality control department did not undertake all of the required activities.
Inspection Record
Reckitt Benckiser (Canada) Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
Periodic confirmatory testing was not conducted. The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
3Labeling and packaging
The importer did not ensure that the foreign sites use to fabricate, package/label, or test drug products met the requirements described in Guidance on Evidence to Demonstrate Drug GMP Compliance of Foreign Sites (GUI-0080).
4Other quality system
The assessment to release finished products was inadequate.
5Other quality system
Documents were not available on the premises. Documents were not available in one of the official languages.
6Other quality system
The implementation of a self-inspection program was inadequate.
7Other quality system
The written specifications were inadequate.
8Equipment and facility
The ongoing stability program for a drug was inadequate. "The maintenance of records was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2024-08-27. 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.
