NHS Clarkson West Medical Center – FDA Warning Letter, Aug 28, 2008

On June 26 and August 28, 2008, the FDA inspected Clarkson West Medical Center, revealing a serious problem with mammography conduct. The facility failed to produce documents verifying that a radiologic technologist met the continuing experience requirement of performing 200 mammography examinations in 24 months, violating 21 CFR 900.12(a)(2)(iv)(A) of the Mammography Quality Standards Act of 1992 (MQSA).

This violation indicates potential underlying problems compromising mammography quality. The FDA may take additional actions, 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 seeking a court injunction. A Compliance Follow-up Inspection may be performed.

The facility must respond in writing to the FDA within 15 working days of receiving the letter. The response must detail specific steps taken or planned to correct all violations, including projected timeframes, and steps to prevent recurrence, also with timeframes. Sample records demonstrating proper record-keeping procedures must be included. The letter emphasizes that this pertains only to violations from the recent inspection and does not address all MQSA obligations.