FDA WARNING_LETTER - Medisound Inc - November 16, 2009

FDA issued Warning Letter FLA-10-09 to Medisound, Inc. on January 22, 2010, following an MQSA inspection on November 16, 2009. The inspection revealed serious, and in some cases repeat, violations concerning mammography quality standards (21 CFR 900.12). Deficiencies included failure to provide documentation for a radiologic technologist's initial license/certificate and continuing education, and for an interpreting physician's continuing education. The facility also failed to follow manufacturer QC procedures for its full field digital mammography device, printer, and monitor, and exceeded the required survey interval for Digital Unit #1. Furthermore, a radiologic technologist lacked documentation for initial 40 contact hours of mammography training and 8 hours in each modality. The facility's December 3, 2009, response was deemed inadequate due to insufficient documentation of corrections, suggesting serious underlying issues. FDA warned of potential enforcement actions, including an Additional Mammography Review, a Directed Plan of Correction, civil money penalties up to $10,000 per violation, and certificate suspension or revocation. Medisound, Inc. must submit a written response within fifteen working days detailing corrective actions, preventative measures, and timeframes to FDA and the State of Florida.