1Regulatory reporting and change control
The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.
Inspection Record
Laboratoire Riva Inc. — Health Canada Inspection Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The evidence required to demonstrate compliance with finished product specifications was inadequate. The positive identification of each batch of drug after the packaging and/or after it was received on the importer's premises was inadequate.
3Equipment and facility
The maintenance of records was inadequate.
4Other quality system
Complete testing was not performed according to the requirements. The confirmatory tests conducted on samples before or after they were received in Canada were inadequate.
5Cleaning validation
The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.
6Material and supplier control
The standard operating procedures or records for shipping and receiving raw materials were inadequate.
7Other quality system
The recorded information or details were inadequate.
8Stability and storage
The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.
9Other quality system
The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.
10Material and supplier control
The packaging materials vendor certification program was inadequate.
11Laboratory and QC controls
The written protocol and/or the assessment of the test method transfer was inadequate.
12Labeling 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).
13Stability and storage
Reworked or reprocessed drug lots were not included in the ongoing stability program. The ongoing stability program for a drug was inadequate.
About this record
Extracted automatically from the document of the Health Canada inspection on 2022-09-13. 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.
