FDA 483 - Horizon Pharmaceuticals, Inc. - February 16, 2024

Horizon Pharmaceuticals, Inc., a sterile drug manufacturer in Riviera Beach, FL, received a Form 483 citing significant deficiencies across its quality system, laboratory controls, and facilities. The inspection revealed a lack of adequate quality control unit oversight, incomplete investigations into environmental monitoring excursions, and failures in complaint handling, vendor qualification, and batch record review. These issues indicate a systemic breakdown in ensuring the quality and sterility of its arformoterol tartrate inhalation solution.