United Medical Center – FDA Warning Letter, Apr 10, 2012

An FDA inspection on April 10, 2012, at Not For Profit Hospital Corp. dba United Medical Center revealed serious violations of the Mammography Quality Standards Act (MQSA). Key deficiencies included a repeat Level 1 violation for an inadequate system to provide timely mammography reports to healthcare providers within 30 days, as required by 21 CFR 900.12(c)(3)(i). A Level 2 violation noted one of ten random reports lacked an acceptable assessment category, using "Highly Suspicious for Malignancy" (21 CFR 900.12(c)(1)(iv)(E)). Additionally, repeat Level 3 violations cited the unavailability of required personnel qualification documents (21 CFR 900.12(a)(4)) and a darkroom fog density of 0.07 (21 CFR Part 900.12(e)(4)(i)). The facility's April 20, 2012, response was deemed inadequate, particularly due to the recurring nature of some violations, indicating a failure to implement permanent corrections. The FDA warned that continued non-compliance could lead to severe actions, including an Additional Mammography Review, a Directed Plan of Correction, civil money penalties up to $10,000 per violation, and suspension or revocation of the facility's FDA certificate. A Compliance Follow-up Inspection will be conducted to verify corrections.