FDA 483 - McCallum Manufacturing Limited - September 15, 2023

McCallum Manufacturing Ltd, an OTC drug and cosmetic manufacturer in Barnsley, South Yorkshire, was inspected by the FDA from September 11-15, 2023. The inspection revealed significant deficiencies across multiple areas of their manufacturing operations, including inadequate product and component testing, lack of validated cleaning procedures, insufficient quality control oversight, and a deficient stability program. These issues indicate a systemic failure to adhere to cGMP requirements, potentially impacting the identity, strength, quality, and purity of drug products released to the US market.