FDA 483 - Jamol Laboratories, Inc. - January 12, 2023

Jamol Laboratories, Inc. in Emerson, NJ, was inspected regarding its finished drug product manufacturing. The inspection revealed significant deficiencies in process validation, facility maintenance and cleanliness, investigation of product discrepancies, and completeness of batch production records, particularly concerning their Ponaris® OTC drug product. These issues indicate a lack of adequate controls to ensure product quality and consistency.