FDA WARNING_LETTER - Obstetrics Gynecology, Ltd

On September 23, 2013, an FDA inspection at Obstetrics-Gynecology Ltd. in Pine Bluff, AR, revealed serious mammography quality violations under the Mammography Quality Standards Act of 1992 (MQSA). The facility, owned by Ruston Pierce, M.D., was cited for four violations.

Level 1 violations included missing processor QC records for at least 30% of operating days in July 2013 and for at least 5 consecutive days, both violating 21 CFR 900.12(e)(1). Additionally, phantom QC records were missing for at least four weeks, violating 21 CFR 900.12(e)(2). A Level 2 violation noted that medical audit and outcome analysis was not performed separately for each individual physician, contrary to 21 CFR 900.12(f)(1).

The facility responded on October 2, 2013, indicating corrective actions were implemented. However, the FDA warned that these violations suggest serious underlying problems that could compromise mammography quality. Potential additional actions include an Additional Mammography Review, a Directed Plan of Correction, charges for on-site monitoring, patient/physician notification of deficiencies, civil money penalties up to $10,000 per violation/day, suspension/revocation of the FDA certificate, or a court injunction (42 USC