FDA 483 - Millers of Wyckoff, Inc. - May 18, 2017

An FDA inspection conducted at Millers of Wyckoff, Inc. between April 4 and May 18, 2017, revealed significant deficiencies in the production of sterile and non-sterile drug products. The company failed to establish expiration dates for drug products, such as Coenzyme Q-10 in Oil injectable, with supporting stability data. Numerous drug product batches, including sterile injectables and compounded capsules, were released for distribution without adequate potency testing for active ingredients. Essential sterility and endotoxin testing were also omitted for sterile products like Coenzyme Q-10 in Oil injectable and Mineral Mix. Additionally, the firm neglected to verify the identity of active pharmaceutical ingredients prior to use. Environmental controls in aseptic processing areas, specifically ISO 5 and ISO 7 cleanrooms, were inadequate, with deficiencies in personnel and particulate monitoring. The disinfection program lacked sufficient data to support cleaning agent contact times. These observations indicate a failure to adhere to current Good Manufacturing Practices, requiring Millers of Wyckoff, Inc. to implement robust corrective and preventive actions to achieve compliance.