FDA 483 - Copperhead Chemical Company, Inc. - April 24, 2023
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Copperhead Chemical Company, Inc. in Tamaqua, PA, was inspected by the FDA from April 17-24, 2023, and received a Form 483 with three observations. The inspection revealed significant issues related to inadequate discrepancy investigations, insufficient calibration of critical equipment used in nitroglycerin production, and a lack of data integrity controls for analytical testing systems. These findings indicate serious deficiencies in the firm's quality control and data management practices.
ID · 41c87bca-c494-4360-ae3c-b6869cfe6745