FDA 483 - Speciality Pharma Manufacturing, LLC - April 08, 2025

An FDA inspection of Speciality Pharma Manufacturing, LLC in Carlstadt, NJ, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to adequately test finished drug products and raw materials, establish proper process and cleaning validations, and maintain appropriate equipment qualification and stability assessments. These issues indicate a systemic lack of control over drug product identity, strength, purity, and quality.