Dr. Reddy's Laboratories Canada Inc — Health Canada Inspection Findings

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).

The implementation of a self-inspection program was inadequate.

The written procedures for recalls were inadequate.

The assessment to release finished products was inadequate.

The training of personnel in good manufacturing practices and/or the maintenance of records was inadequate.

Complete testing was not performed according to the requirements.

The change control system was inadequate for ensuring changes are properly documented, evaluated, and/or approved.

The company did not assess the results and/or take corrective actions for stability testing results that were out-of-specification, borderline, or out-of-trend .

The availability, content and/or maintenance of the quality agreements between the supplier, fabricator, tester, packager, labeller, distributor, importer, and/or wholesaler was inadequate.

The annual product quality review procedure was inadequate.

Deficiencies were noted with the procedure for the assessment of returned drugs being considered for resale.

The assessment, recording, follow-up, and/or investigation of complaints and/or other information about potentially defective products was inadequate.

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

To confirm the shelf life of the drug, the company did not use at least three commercial-scale batches of the drug for every strength of the drug and the approved packaging material.

Test methods were not validated or the method transfer studies were not conducted. The evidence required to demonstrate compliance with finished product specifications was inadequate.