FDA 483 - Syenz Laboratory, LLC - September 30, 2022

An FDA inspection of Syenz Laboratory, LLC in Norwood, NJ, a control testing laboratory and own label distributor, revealed significant deficiencies across its quality control unit, laboratory operations, and data integrity. The firm failed to adhere to its own procedures for training, recall, and vendor qualification, and lacked appropriate computer controls for chromatographic data. Furthermore, the inspection found incomplete laboratory records, unestablished and deficient test methods for proposed drug products, and a lack of scientifically sound specifications, indicating a broad failure to comply with cGMP requirements.