Factors Group of Nutritional Companies Inc. — Health Canada Inspection Findings

Packaging operations were not performed in keeping with the written operating procedures or specifications. The handling of rejected materials and products was inadequate.

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

As the manufacturing steps were completed, the information was not recorded in the manufacturing batch record. The master formulas to control the manufacturing process were inadequate. Investigations into deviations, reports, and/or follow-up actions were inadequate.

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

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The electronic system was not validated for its intended use.

The guidelines and/or procedures were inadequate in ensuring storage and/or transportation conditions would maintain the quality and safe distribution of the drug.

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

The assessment to release finished products was inadequate.

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

The validation and/or the documentation of test methods was inadequate. The traceability, legibility, documentation, formatting, and/or the accuracy of records was inadequate.

The implementation and/or the effectiveness of the sanitation program in preventing unsanitary conditions was inadequate. The monitoring procedures for microbial and/or environmental conditions were inadequate.