FDA Remembers All Submissions: New Jersey Clinic Learned this Lesson
(Thursday, February 9, 2023)
All submissions made to the FDA by an organization are reviewed and tallied to previous submissions made by the same organization, person, locations and other identifiers. The FDA keeps track of all submissions and any deficiencies identified are tracked as well to assure that non-compliance is addressed. Occasionally events happen that demonstrate this fact. Between 2020 and 2022, a mammography imaging center in New Jersey, that failed repeated quality inspections by FDA, tried resubmitting its quality certificate applications by changing the name and altering the address of the facility, presumably assuming that FDA would not tally previous submissions to find the fake resubmissions. Each attempt was unsuccessful and finally led to the blacklisting of the facility and its two owners by the FDA this week. The case is both egregious and comical. It is hard to imagine what the owners of the facility were assuming when they re-submitted the registration application of their facility four times with slightly altered business names and slightly altered mailing addresses. The only logical explanation seems to be that the owners assumed that they would slip through the cracks. Each time their facility registration was cancelled or withdrawn, they would resubmit a few days later (once as soon as the next day after withdrawing the registration) without addressing the reasons for the previous rejection. And each time, they were caught, thankfully. It should not come as a surprise that the FDA looked carefully at each application, sent its inspectors to verify, worked with other related agencies, and denied certification of a non-compliant facility. In fact, one should expect such diligence from the FDA. The FDA is not a very communicative organization. It maintains a policy to respond to a submission only if there are any issues with the submission. Unlike drug regulatory agencies in other countries, most submissions to FDA do not elicit an “approval letter” except for automated boilerplate messages acknowledging the receipt of a submission, if at all. “No news is good news” when it comes to FDA. This gives a false impression to many that their submissions are not reviewed by the Agency. But in fact, each submission is reviewed and compared to any previous submissions by the same or related submitters by designated FDA staffers and internal actions taken. The New Jersey facility owners, who were oblivious to this FDA process, decided that deceiving was easier than addressing the quality issue, to their detriment. This is a rare event. There are 8790 FDA-certified mammography facilities in the US and this is the third facility in the country whose FDA certificates were revoked. So, this case is just a demonstration that the system works and does not indicate dangerous mammography centers in the country. This should come as a relief to any patients using these facilities across the country.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC