FDA WARNING_LETTER - Mark Berman, M.D. - July 13, 2018

On February 13, 2019, the FDA issued a Warning Letter to Mark Berman, M.D., following a July 9-13, 2018 inspection of his Beverly Hills facility. The inspection revealed that Dr. Berman manufactures and markets the "Pocket Protector," a device intended for use in breast augmentation procedures. The FDA determined this product is a Class III device requiring premarket approval (PMA).

The Pocket Protector is deemed adulterated because Dr. Berman lacks an approved PMA or an approved Investigational Device Exemption (IDE). His IDE application was disapproved in July 2017 due to deficiencies. The device is also misbranded as the firm failed to notify the FDA of its intent to commercially distribute it. The FDA rejected Dr. Berman's assertion that the device qualifies for a custom device exemption, citing failure to submit annual reports, production exceeding five units per year, and non-compliance with other custom device requirements.

The inspection also found the Pocket Protector adulterated due to numerous Quality System (QS) regulation violations (21 CFR Part 820), including: - Failure to establish design control procedures (21 CFR 820.30). - Lack of procedures for controlling purchased products and services (21 CFR 820.50). - Failure to control production processes, including lack of clean rooms, equipment calibration records, and sterilization documentation (21 CFR 8