FDA 483 - Nice-Pak Products, Inc. - April 20, 2026

An FDA inspection of Nice-Pak Products, LLC in Mooresville, IN, revealed significant deficiencies in their manufacturing processes for non-sterile OTC drug products. Observations included a lack of cleaning validation for shared equipment, an inadequate environmental monitoring program that omitted critical product-contact surfaces, and poor facility maintenance with damaged and contaminated ceiling tiles directly above production areas. These issues pose a direct risk of contamination to drug products.