FDA 483 - Health Specialty - November 30, 2023

An FDA inspection of Health Specialty in Santa Fe Springs, CA, revealed significant deficiencies across multiple areas of their drug manufacturing operations. The firm failed to adhere to quality control procedures, provide adequate employee training, establish proper production and process controls, and ensure appropriate equipment design. Additionally, issues were noted with stability testing for expiration dates and the validation of analytical test methods, indicating a broad lack of compliance with good manufacturing practices.