FDA WARNING_LETTER - Eiber Radiology, Inc. - July 19, 2011

On July 19, 2011, the FDA inspected Eiber Radiology, Inc., revealing serious MQSA violations. The facility failed to provide documentation verifying that the interpreting physician, Alberto Eiber, M.D., met the continuing education requirement of fifteen (15) category 1 continuing medical education units in mammography within thirty-six (36) months, as per 21 CFR 900.12(a)(1)(ii)(B) & (a)(4).

Additionally, the facility failed to produce documents verifying Dr. Eiber met the continuing experience requirement of interpreting or multi-reading nine hundred sixty (960) mammograms in twenty-four (24) months. Records showed significantly fewer mammograms interpreted: 90 in 2009, 38 in 2010, and 222 from January to April 2011. This contradicts the "1,200" mammograms reported on an ACR form signed by Dr. Eiber on February 9, 2011. These are Level 2 violations under 21 CFR 900.12(a)(1)(ii)(A) & (a)(4).

Continued failure to resolve these issues may lead to further FDA actions, including Additional Mammography Review, a Directed Plan of Correction, civil money penalties up to $10,000 per