483
Copperhead Chemical Company, Inc.FDA 483 - Copperhead Chemical Company, Inc. - June 18, 2026
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An FDA inspection of Copperhead Chemical Company, Inc. in Tamaqua, PA, revealed significant deficiencies in manufacturing controls. Observations included inadequate cleaning validation for API drug substance equipment, insufficient out-of-specification investigation processes, and improper monitoring of warehouse storage temperatures. These issues indicate a lack of robust quality systems.
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ID · 2971b050-4bb0-4e96-a1c1-e95d4a5837ec