FDA Inspections on Hold — But They’ll be Back. The Question is, Will You Be Ready? Highlights from FDLI’s Enforcement, Litigation, and Compliance Conference

Jack Garvey |

Now that the dust has settled from FDLI’s Enforcement, Litigation, and Compliance Conference and everyone is back to the new normal (Zoom calls, casual clothes and longer hours) we’ve had time to process our highlights from this great event. We’re proud to have once again served as a Gold Sponsor.

First off, as usual, FDLI delivered an impressive line-up of speakers from FDA, industry, and outside counsel. No matter what area of FDA regulated industry you work in, there were excellent sessions — many hosted by the FDA’s top officials from the various Centers and HQ.

The event’s opening plenary session featured directors from the FDA’s Office of Compliance for all the major Centers. The session was led by Daniel Kracov, Partner, Arnold & Porter and Vice Chair, FDLI Board of Directors. The directors’ comments were primarily focused on how the Centers have managed operations during 2020 given the monumental changes brought on by the COVID-19 pandemic. Three major topics were highlighted:

  1. The avalanche of Emergency Use Authorizations and how FDA has been working with industry to efficiently process the applications while speeding products to market and maintaining product safety. CDRH stated they have received nearly 3,000 EUAs since the start of the pandemic.
  2. Aggressively combating fraudulent COVID-19 “miracle cures.” Directors from various Centers described unapproved products that flooded the market hoping for a quick buck from uninformed consumers. These included stems cells, exosomes, diagnostic tests, nasal sprays, and botanical oils. CDER’s Donald Ashley also spoke about poor quality and unsafe hand sanitizers that entered the market by way of new entrants.
  3. Last, but certainly not least, FDA Center directors discussed the suspension of foreign and significantly reduced domestic inspections. Each Center is exploring alternative means to maintain the safety and efficacy of marketed products. Most Centers are conducting record request-style inspections and or deferring inspections until an unknown time in the future. Each Center noted that “mission-critical” inspections will continue.

Another session of note was on Quality Risk Management (QRM) During a Pandemic and After. Of particular interest is what’s a company’s QMS system going to look like when the pandemic is over. Will companies use this unique period in history to improve their QMS or let it suffer while the inspection “heat” is off?  Session participants mentioned two area of particular interest; supplier management and change control.

Given the disruption in supply chains caused by the pandemic, managing your suppliers — some whom you may have rarely used before, or are completely new to you — is paramount. Taking a risk-based approach to qualification, review, selection and receipt of materials is more crucial than ever.

Additionally, this pandemic has radically changed nearly everything in business and FDA-regulated companies are at the forefront. With our complex products, managing change control is a daily occurrence.  The dramatic changes COVID has brought deserve your undivided attention.  Reviewing your change control program now is money well spent. As the old adage says, it’s “pay now, or pay more later.”

In closing, remember one thing — inspections will come back. FDA’s investigators are itching to get out of their home offices and scour plant floors, interview your SMEs, dig into your QMS and plow through your records.

If in 2021 you feel like an extra set of eyes could help fix any known concerns or just reassure you that you’ve got all this craziness covered, don’t hesitate to reach out to Jeff Grizzel, VP of Business Development, 703-587-8990, jeff.grizzel@compliancearchiects.com.

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