EverZinc — Health Canada Inspection Findings

The quarantine, sampling, testing, release of raw material, and/or the packaging materials prior to use were inadequate. The assessment to release finished products was inadequate.

The evidence used to demonstrate the transportation and/or storage conditions of each lot or batch of the drug was inadequate.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record.

The assessment, documentation, and/or procedures for considering the resale of returned drugs were inadequate.

"The maintenance of records was inadequate.

The validation and/or the documentation of test methods was inadequate. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. Investigations into deviations, reports, and/or follow-up actions were inadequate. The receipt, preparation, and/or handling of reagents and culture media was inadequate.

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

The preventative maintenance program was inadequate for the equipment used in significant processing and/or testing operations.

Separating each batch of the same delivery for sampling, testing, or release was inadequate.

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