How to Guarantee a Complete FDA Inspection Failure

An FDA inspection represents a challenging and often stressful situation for most companies. A new Warning Letter, published on the FDA's website on 24 December 2024, documents a case where the pressure apparently became too much to handle. The letter goes back to an inspection conducted from 17 to 21 June 2024, at a drug manufacturing facility in Newmarket, Canada.

Obstruction of the Inspection

The Warning Letter begins with a detailed account of how the company's actions obstructed the inspection. These incidents include the following:

• The Quality Manager shouted at the inspectors after learning that they had continued their conversation with the Quality Control Supervisor from the previous day without his presence on the second day of the inspection.
• Laboratory staff refused to open a stability chamber.
• When inspectors attempted to question specific employees, they were repeatedly interrupted by the Quality Manager, who also interfered with the employees' responses. In one case, the Quality Manager began berating an employee, who then left the room.
• Crucial documents relevant to the inspection, such as temperature records and complaint reports, were either not provided or were submitted incomplete.

CGMP Violations

Despite these significant obstructions, the inspection uncovered numerous CGMP deficiencies:

• Complaints and recalls: A customer complaint regarding mold contamination was not adequately investigated. Only two batches were recalled, even though it could not be demonstrated that the contamination was limited to these batches.
• Lack of analytical testing and validation: The Quality Unit (QU) released multiple batches of drug products without performing active ingredient assay and test methods were not validated. Active pharmaceutical ingredients (APIs) were released based on the supplier’s certificates of analysis (COAs) without establishing the reliability of test analyses at appropriate intervals.
• Inadequate Storage Conditions: Truck trailers scattered across the property were used for the storage of components, finished products, and other items. These trailers were not climate controlled, and the exact contents were unclear. One API was stored outdoors and exposed to the elements.
• Pest control: Pest traps inside the raw material storage area were covered with filth and insects, and reports from the pest control service provider showed an ongoing pest issue.
• Missing validations and stability studies: Reports for process and cleaning validations were missing, as were stability studies to substantiate the labeled expiry of the products.

Corrective Actions

The FDA has required the company to submit a detailed plan to address these deficiencies within 15 working days of receiving the Warning Letter and to implement immediate corrective actions.

Further details can be found in the complete Warning Letter available on the FDA's website.