FDA 483 - Tenda Horse Products LLC - May 17, 2024

An FDA inspection of Tenda Horse Products LLC, a contract manufacturer of animal drug products in Sandusky, OH, revealed significant deficiencies across multiple areas of its manufacturing operations. The firm failed to adequately investigate out-of-specification results and deviations, lacked proper controls for its water system and method validation, and did not provide current good manufacturing practices (CGMP) training to employees. Additionally, the inspection found issues with equipment cleaning logs, batch record documentation, and instrument calibration procedures.