Jazz Pharmaceuticals Canada Inc. — Health Canada Inspection Findings

The availability or the content of the authentic certificate of analysis was inadequate. The written specifications were inadequate.

Investigations into deviations, reports, and/or follow-up actions were inadequate.

The annual product quality review procedure was inadequate.

The master production documents were inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The ongoing stability program for a drug was inadequate.

For imported products, the stability studies from foreign sites were not compliant with Canadian good manufacturing practices and/or Canadian marketing authorization.

The handling of standard operating procedures for good manufacturing practices was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.