FDA EIR - F. M. Howell & Company Inc. - September 08, 2020

An FDA inspection of F. M. Howell & Company Inc. in Elmira, NY, occurred from September 3 to September 8, 2020. This routine review focused on the firm's operations as a secondary re-packager and re-labeler of prescription drug products and medical devices. The inspection was conducted in accordance with the regulatory framework for drug re-packagers and re-labelers, emphasizing compliance with current Good Manufacturing Practices.

The inspection evaluated the company’s Training Program, Quality System, and Packaging/Labeling System. No formal FDA Form 483, detailing inspectional observations, was issued, indicating a generally compliant operation. However, a key discussion point involved the handling and documentation of quarantined materials. Inspectors identified product pallets in a non-quarantine area bearing "Released under Quarantine" labels, which initially caused confusion among management. This situation was later clarified as an established procedure from an overseas contract manufacturer, where products are shipped with a provisional quarantine status.

In response, F. M. Howell & Company Inc. agreed to improve their procedures by being more diligent in removing quarantine notices once the necessary release documentation is obtained. Furthermore, the company committed to providing specific training to warehouse personnel to ensure they recognize and properly address products received with quarantine signage. The firm's role remains limited to secondary packaging, not the manufacturing of drug products.