FDA WARNING_LETTER - Healthcare Authority of the City of Demopolis - January 31, 2011

On September 30, 2010, and January 31, 2011, Bryan W. Whitfield Memorial Hospital (BWWMH) was inspected by the State of Alabama, Department of Public Health, Office of Radiation Control, under contract to the FDA. The inspections revealed violations of the Mammography Quality Standards Act of 1992 (MQSA) and 21 CFR 900.12.

Key violations include: - **Level 2:** The phantom image score was less than 3 speck groups, with too many speck-like artifacts on the QC film, making it difficult to read. This indicates a failure of the entire imaging system (x-ray unit, processor, darkroom, and image receptor) to function properly and consistently. The facility must correct this issue before conducting clinical examinations using the affected system. - **Level 3:** Fixer retention QC tests were not performed at the required frequency for processor (b)(4).

These noncompliance issues may indicate serious underlying problems compromising mammography quality. Potential FDA actions include requiring an Additional Mammography Review, a Directed Plan of Correction, charging for on-site monitoring, patient/physician notification, civil money penalties up to $11,000 per violation/day, suspension/revocation of the FDA certificate, or a court injunction.

BWWMH must respond in writing within fifteen working days, detailing specific corrective actions