FDA WARNING_LETTER - Hudson Radiology Center - January 06, 2014

On January 28, 2014, the FDA issued a Warning Letter to Hudson Radiology Center of NJ, following an MQSA inspection on April 29, 2013, and a follow-up inspection on January 6, 2014. The initial inspection revealed serious violations of the Mammography Quality Standards Act of 1992 (MQSA) at their Bayonne, NJ facility.

Violations included: - Failure to follow manufacturer QC procedures for the FFDM unit, printer, and monitor for digital unit 3 (Lorad/Hologic). [21 CFR 900.12(e)(6)] - Failure to provide documentation that interpreting physician JOHN LYONS had 8 hours of training in the new mammographic modality. [21 CFR 900.12(a)(1)(ii)(C)] - Deficiencies in medical audit and outcome analysis, specifically: not performed separately for each individual, not performed annually, and no designated audit interpreting physician. [21 CFR 900.12(f)(1), (2), (3)]

The facility failed to respond to the initial inspection report and subsequent communications. The January 6, 2014, follow-up inspection confirmed that all previously identified violations remained uncorrected.

The FDA warned that continued non-compliance could lead to further actions, including an Additional Mammography Review