Copperhead Chemical Company, Inc. – FDA EIR, Apr 24, 2023

An FDA Pre-Approval and surveillance inspection of Copperhead Chemical Company, Inc. in Tamaqua, PA, was conducted from April 17-24, 2023. The inspection aimed to provide Good Manufacturing Practice (GMP) surveillance and Pre-Approval Inspection (PAI) coverage for the company as a manufacturer of Active Pharmaceutical Ingredients (APIs), specifically SDM® 27, 10% Nitroglycerin in Propylene Glycol, USP. The regulatory framework for this inspection included Compliance Programs for Active Pharmaceutical Ingredient Process Inspection and Pre-Approval Inspections, upholding the Federal Food, Drug and Cosmetic Act and drug GMPs. Upon conclusion, a three-item FDA Form 483, Inspectional Observations, was issued. Key observations included a failure to thoroughly review unexplained discrepancies, particularly regarding recurring equipment calibration failures for critical weighing scales, and a lack of adequate product quality impact assessments or corrective actions. The inspection also noted that routine calibration of mechanical equipment was not performed according to a written program, and appropriate controls were not exercised over computer systems to ensure changes to master production records were made by authorized personnel, raising data integrity concerns. Management was required to submit a written response to the observations within 15 business days.