FDA 483 - Signature Formulations, LLC - November 09, 2017

An FDA inspection of Signature Formulations, LLC in Phoenix, AZ, a manufacturer and own-label distributor of drug products, revealed significant deficiencies across its quality, materials, laboratory, production, and facilities systems. The firm lacked fundamental controls, including adequate quality unit oversight, proper component and finished product testing, validated water systems, and complete batch and master production records. These findings indicate a severe lack of adherence to current Good Manufacturing Practices.