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

The sanitation program was inadequate in its cleaning procedures, frequency of cleaning, procedures for waste disposal, and/or pest control measures.

The design, equipment, and/or maintenance of the testing laboratory was inadequate.

The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records.

The premises and/or the manufacturing process were inadequate for minimizing contamination of the drugs and/or materials during fabrication and/or packaging.

Packaging operations were not performed in keeping with the written operating procedures or specifications.

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

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

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

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

The electronic system was not validated for its intended use. The controls were inadequate for creating, modifying, reviewing, storing, and/or retrieving records. The design, equipment, and/or maintenance of the testing laboratory was inadequate.

There was a lack of or inadequate evidence to demonstrate that all buildings involved in the production, distribution and/or importation of APIs met good manufacturing practices requirements.