Acuity Specialty Products, Inc – FDA 483, Mar 14, 2025

Acuity Specialty Products, Inc. in Chambersburg, PA, was inspected and cited for numerous significant deficiencies related to its manufacturing of OTC drug products, primarily hand sanitizers. The inspection revealed widespread issues in quality control, including inadequate testing of raw materials, unvalidated test methods, and a lack of process and equipment validation. Several observations were repeat deficiencies from previous inspections, indicating persistent non-compliance with cGMP regulations.