FDA WARNING_LETTER - Mesquite Diagnostics - July 01, 2008

On July 1, 2008, an inspection conducted by the State of Texas on behalf of the FDA at Mesquite Diagnostics revealed a serious violation of the Mammography Quality Standards Act (MQSA). The facility was found to be performing mammography without a valid certificate, a direct violation of 21 CFR 900.11(a). This deficiency indicates potential underlying issues that could compromise the quality of mammography services. The FDA warned that additional actions might be taken, including requiring an Additional Mammography Review, implementing a Directed Plan of Correction, charging for on-site monitoring, requiring patient and physician notification of deficiencies, seeking civil money penalties up to $11,000 per violation, suspending or revoking the facility's FDA certificate, or pursuing a court injunction, as outlined in 42 USC 263b(h)-(j) and 21 CFR 900.12(j). Mesquite Diagnostics was required to respond in writing within 15 working days, detailing specific corrective actions taken or planned, including timeframes, steps to prevent recurrence, and sample record-keeping procedures. A Compliance Follow-up Inspection may be conducted to ensure all problems are corrected.