FDA 483 - Empower Clinic Services New Jersey, LLC - November 18, 2024

An FDA inspection of Empower Clinic Services New Jersey, LLC in East Windsor, NJ, revealed significant deficiencies in quality control, production, and laboratory operations. The firm failed to properly review and approve procedures, adequately investigate microbial contamination during water system qualifications, and perform necessary instrument and method validations. These issues indicate a lack of robust controls over drug product quality and data integrity.