Hospital Bella Vista – FDA Warning Letter

On September 13, 2012, the FDA issued a Warning Letter to Hospital Bella Vista following an inspection on May 9, 2011, by a State representative acting on behalf of the FDA. The inspection, identified by ID: 2248250010, found a repeat violation of the Mammography Quality Standards Act of 1992 (MQSA).

The specific violation, categorized as Level 2, was the facility's failure to produce documents verifying that interpreting physician Gilberto Franceschini met the continuing experience requirement of having interpreted, or multi-read, 960 mammograms in 24 months. This violation was previously observed during inspections on May 12, 2009, and May 24, 2010, and was noted on the MQSA Facility Inspection Report and "Important Information about Your MQSA Inspection" faxed on May 16, 2011. The regulatory citations for this violation are 21 CFR 900.12(a)(1)(ii)(A) and 900.12(a)(1)(iv)(A)(1)(2) and (3).

The facility's written response dated June 9, 2011, was deemed inadequate due to insufficient documentation of corrections and a failure to respond to subsequent communication attempts on June 14,