The Hudson Radiology Center of New Jersey, located at 657-659 Broadway in Bayonne, New Jersey, has been cited for more than a dozen violations of the Mammography Quality Standards Act of 1992 (MQSA). Although FDA issued the citation on January 28th of this year, it was only posted on the FDA Enforcment Actions website within the past week.
Violations listed in the letter, which is signed by Diana Amador Toro, director of the New Jersey District of the Public Health Service, include failure to follow manufacturer-recommended procedures for mammography monitors and lack of a designated audit interpreting physician for the company's facility in Bayonne. The letter cautions the facility that FDA may pursue several different options if the violations are not remediated, including seeking the suspension or revocation of the facility's FDA certificate.
This is not the first mammography quality scandal to hit the news in recent days. On Monday of this week, FDA issued a safety communication regarding Big Sky Diagnostic Imaging, LLC, in Butte, Montana. The government agency notified women who had undergone mammography on any date after November 19, 2011, that quality problems at the facility may have affected their mammograms. Although FDA stated that "this does not mean that the results of the examinations were inaccurate," the agency did instruct women who received mammograms from Big Sky to visit their personal physicians to determine whether repeat mammography is advisable.
Consumers interested in receiving safety communications from FDA should visit the government's website to sign up.