Aqualitas Inc. — Health Canada Inspection Findings

Each container of a lot of raw materials was not tested to identify its contents with a specific, discriminating test.

The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.

The health examinations of personnel (pre-employment and/or ongoing) were inadequate.

The segregation, rotation of stock, and/or the transportation of raw materials, packaging materials, intermediates, bulk drugs, and/or finished products was inadequate. Evaluation of production processes, equipment, and/or materials was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate.

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 .

Printed packaging materials were not stored in an area with restricted access. The handling of rejected materials and products was inadequate.

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging. The premises were not designed, constructed, operated, and/or maintained to allow clean and orderly conditions.

Critical production processes were not validated.

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

The calibration, inspection, and/or qualification of the equipment, including computerized systems, was inadequate. Measuring devices were not regularly checked for accuracy and precision.