FDA WARNING_LETTER - Union Square Medical Imaging & Mammography - February 11, 2014

On January 29 and February 11, 2014, an FDA inspection of Union Square Medical Imaging & Mammography, P.C. revealed serious violations of the Mammography Quality Standards Act (MQSA).

Key violations include: - **Level 1:** Missing phantom QC records for unit 3 for over 4 weeks during a 12-week period (21 CFR 900.12(e)(2) and (d)(2)). - **Level 2:** Failure to follow FFDM manufacturer QC procedures (excluding monitor & printer QC) for digital unit 3 (21 CFR 900.12(e)(6)). - **Level 2:** Failure to follow manufacturer recommended QC procedures for the monitor of digital unit 3 (21 CFR 900.12(e)(6)). - **Level 2:** Failure to produce documentation verifying an interpreting physician met continuing education requirements (21 CFR 900.12(a)(1)(ii)(B)). - **Level 2:** Failure to produce documentation verifying multiple radiologic technologists met continuing experience requirements (200 mammography exams in 24 months) and/or 8 hours of training in each mammographic modality (21 CFR 900.12(a)(2)(iv)(A), 21 CFR 900.12(