FDA 483 - Jamol Laboratories, Inc. - December 12, 2024

Jamol Laboratories, Inc. in Emerson, NJ, was inspected and cited for significant deficiencies in its manufacturing operations for Ponaris® Nasal Emollient. The inspection revealed failures in establishing adequate production and process controls, qualifying equipment, thoroughly investigating customer complaints, maintaining proper laboratory controls, and ensuring suitable facility conditions. These issues indicate a lack of adherence to current Good Manufacturing Practices, potentially impacting the quality and safety of its OTC drug products.