FDA 483 - Nana Barseghian, M.D. - February 16, 2024

An FDA inspection conducted at X-Ray Associates of Port Huron PC from May 18 to May 29, 2015, identified several significant deviations from federal quality standards for mammography facilities. The facility was cited for multiple issues, some of which were repeat observations from a previous inspection.Key violations included the failure to perform quarterly repeat analysis for imaging units and the lead interpreting physician's infrequent review of quality control data, with records showing no physician review for an extended period. Furthermore, an interpreting physician did not meet continuing experience requirements, having interpreted significantly fewer mammograms than federally mandated over a 24-month period. The facility also failed to maintain complete personnel records, specifically lacking documentation for the interpreting physician's required continuing medical education units in mammography. Lastly, a review of patient medical reports revealed deficiencies in providing complete information to referring physicians, with several reports missing an overall assessment of findings as required.To achieve compliance, X-Ray Associates of Port Huron PC is required to implement corrective actions to ensure quarterly repeat analyses are conducted, quality control data is regularly reviewed by the lead interpreting physician, all interpreting physicians meet experience and continuing education requirements, and patient medical reports consistently include all necessary diagnostic assessments.