FDA 483 - Sagent Pharmaceuticals - December 18, 2019

Sagent Pharmaceuticals Inc. in Schaumburg, IL, received a Form 483 with seven observations highlighting significant deficiencies in its quality control unit's oversight of contract manufacturers and adherence to procedures. The firm failed to ensure proper approval and rejection of drug products, investigate temperature excursions, and submit timely field alert reports for contamination and out-of-specification products. These issues, coupled with inadequate staffing and documentation errors, indicate a systemic breakdown in quality assurance and regulatory compliance.