FDA 483 - Aidance Skincare and Topical Solutions, LLC - February 12, 2025

Aidance Scientific Inc, a pharmaceutical manufacturer in Woonsocket, RI, was issued a Form FDA 483 with four observations following an inspection. The firm failed to adhere to its quality control unit procedures for product complaint sample testing, maintain equipment to prevent contamination, perform annual visual examinations of reserve samples, and keep proper cleaning and maintenance logs for major equipment. These deficiencies indicate a lack of adherence to good manufacturing practices for their OTC ointment drug products.