Aqualitas Inc. — Health Canada Inspection Findings

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. A preventative maintenance system had not been established for the equipment used in significant processing and/or testing operations

The investigation, handling, and/or reporting of test results that were out-of-specification was inadequate. The analysis of trends for batches of drugs that differed from the norm was inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

The quality control department did not undertake all of the required activities.

The handling of standard operating procedures for good manufacturing practices was inadequate.

The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions. The premises were not designed, constructed, and/or maintained to prevent the entry of pests and/or foreign material into the building.

Validation studies were not conducted in keeping with the predefined protocols.

The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate. The recorded information or details were inadequate.

Complete confirmatory testing was not conducted on raw materials from each vendor. Specific identity testing was not conducted on all lots of raw materials received on the premises. The specifications approved by the quality control department were not available for all raw materials used to produce drugs.

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures. The monitoring procedures for microbial and/or environmental conditions were inadequate. The implementation, effectiveness, and/or validation of the cleaning procedures was inadequate for preventing unsanitary conditions.