FDA WARNING_LETTER - Cardiovascular Diagnostic Image, Inc. - November 23, 2009

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Record Details

On January 22, 2010, the FDA issued a Warning Letter to Edelio Mirabolo Cardiovascular Diagnostic Image, Inc. following a November 20-23, 2009 inspection (ID #216085). The inspection, conducted by Florida State and FDA representatives, revealed serious, repeat violations of the Mammography Quality Standards Act (MQSA) (42 U.S.C. 263b), some of which were also observed in 2007 and 2008.

Key violations (referenced as deviations from 21 CFR 900.12) include: * **Noncompliance Level 2:** * Failure to follow manufacturer QC procedures for Digital Unit #3 FFDM device (repeat, 21 CFR 900.12(e)). * Survey period for Digital Unit #3 exceeded 14 months (repeat, 21 CFR 900.12(e)(9)). * Interpreting physicians (Modar Ashouri, Ralph Dauito) lacked required continuing education (repeat, 21 CFR 900.12(a)(1)(ii)(B)) and continuing experience (repeat, 21 CFR 900.12(a)(1)(ii)(A)). * Dr. Dauito lacked required

Company: Cardiovascular Diagnostic Image, Inc.
Inspection Date: November 23, 2009
Product Type: Devices
Office: Florida District Office
Person: Emma R. Singleton (District Director)

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ID · 3198d152-9e8f-4804-8994-8a510ab90204

Violation Codes10

21 CFR 900.12(e)21 CFR 900.12(e)(9)21 CFR 900.12(a)(1)(ii)(B)21 CFR 900.12(a)(1)(ii)(A)21 CFR 900.12(a)(1)(ii)(C)21 CFR 900.12(c)21 CFR 900.12(a)(1)(i)(D)21 CFR 900.12(a)(1)(i)(C)21 CFR 900.12(a)(2)(iv)21 CFR 900.12(a)(2)(ii)

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