The FDA recently announced that its inspectors may be knocking on your door as early as July 20 to conduct long-overdue domestic inspections. Once given the green light, inspectors’ first priority will be to conduct “mission-critical” inspections of facilities considered to be of the highest risk. But given the world we’re operating in, that actually means very little. In fact, we urge every company to prepare now as if you were FDA Priority #1.
Why?
We don’t know for sure what the FDA deems the most urgent risk. For example, the recently discovered hand sanitizer risks may have caused the agency to shift its priorities in the last couple of weeks. But the agency is also under intense pressure to crack down on produce packers, egg producers and pharmaceutical companies that may have cut corners as they sped up production to meet demand in recent months.
The good news is that “for the foreseeable future,” the FDA will pre-announce inspections. Meaning, in most cases, you’ll get a fair warning that inspectors are on their way. Whether that warning is 24 hours or 24 days, however, here are a few things to think about now:
- FDA will place a focus on high-demand, high-risk product categories. Especially items like hand sanitizer. Even if you are Purell and you’ve been in this game a long time, expect scrutiny. Methanol contamination is no different than NDMA contamination. The FDA is going to be looking for it, so it would be wise to be monitoring your alcohol supplies for contamination and acting quickly to recall if there’s a problem.
- “Bad actors” will be a top priority. These are companies that have recently or repeatedly received warning letters about quality and safety issues. You are likely on the top of the FDA’s list once your state or region is cleared for inspectors to visit.
- Supply chains may be scrutinized. Domestic operations offer FDA officials a glimpse into potential quality issues coming from overseas manufacturers. With the agency still unable to conduct inspections overseas, be prepared for questions about your suppliers and their operations– especially if those partners are on FDA’s watch list.
- FDA will make their usual documentation requests. From adverse event reports to recall compliance documents, FDA will want to see that you’re living up to your regulatory obligations. Assume that it no longer matters whether we’re in a period of enforcement discretion. Have all your records organized and ready to share if asked.
- COVID-19 will not be an acceptable excuse. Sure, it’s an honest reason why our operations and policies have changed, but don’t expect that reason to carry any weight with the inspectors that arrive at your door. One of the FDA’s intentions in notifying you in advance of the inspection is to ensure “the appropriate staff is on-site to assist FDA staff with inspection activities.” Make sure your team is prepared for their arrival, ready to answer questions, deliver on their requests, and help to move things along as expeditiously as possible. Given the risks of COVID-19, it’s very likely that the FDA inspectors will want to wrap up the inspection and move on as quickly as you do.
We knew inspections would resume eventually. But now they are imminent for some companies. Is yours next?