3 Key Takeaways from FDLI’s FDA Center Compliance Directors: Presentations and Q&A Session

FDLI hosted a virtual Enforcement, Litigation, and Compliance Conference December 9–10, 2021.  The session titled Compliance Central with FDA Center Compliance Directors: Presentations and Q&A addressed FDA’s top compliance issues, enforcement priorities, and goals for 2022.  The session included presentations from Ann Oxenham (CFSAN), William Maisel (CDRH), and Donald Ashley (CDER).

Below are key takeaways from some of the panels:

1. CFSAN – Focus on Undeclared Allergens: Ann Oxenham highlighted the division’s 2021 accomplishments, including seizures, injunctions, and warning letters.  In particular, she emphasized warning letters issued for undeclared food allergens, which were the leading cause of class 1 food recalls in the past year.  Oxenham noted that FDA is working to improve industry compliance with regard to food allergen requirements, and is conducting inspections and sampling to check that major food allergens are properly labeled and that food facilities implement appropriate controls.

In 2021, FDA issued seven warning letters to facilities that manufactured and distributed food with undeclared allergens. Oxenham noted that, “although retail establishments are generally excluded from certain requirements, they are responsible for ensuring that the labeling for food manufactured under their brand name and the labeling they perform in the store is accurate with respect to allergens.”  In 2022, CFSAN will continue its particular focus on undeclared allergens.

2. CDRH – FDA Inspection Priorities: William Maisel discussed CDRH’s continued focus on fraudulent COVID-19 products and the status of FDA inspection oversight.  CDRH is currently operating at its base case scenario, with domestic surveillance inspections resuming and foreign inspections occurring if mission-critical.  Maisel noted that CDRH is prioritizing using a risk-based approach, and anticipates the use of remote regulatory assessments for medical device evaluations continuing in the future. 

Maisel also highlighted the increased use of the Medical Device Single Audit Program (MDSAP).  MDSAP allows a recognized third-party auditing organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program, including the FDA.  In the past year, more than 2,000 MDSAP audit reports were used in lieu of FDA surveillance inspections, and FDA will continue to accept MDSAP audit reports as a substitute for routine agency inspections.

In addition, FDA is working to harmonize and modernize the Quality System regulation, with revisions to supplant existing requirements with the specifications of ISO 13485.  Maisel noted that the proposed rule is coming soon.

3. CDER – Novel cGMP Compliance Actions: Donald Ashley highlighted the novel compliance actions developed during the pandemic, including analytical testing of drugs at the border and import alerts.  Some of these measures were developed to address methanol-contaminated hand sanitizers imported into the U.S. and FDA issued the first-ever warning letters based upon analytical testing of samples collected at the border.  FDA also issued the first-ever warning letters based on 704(a)(4) records requests, as well as warning letters based on the refusal of those records requests.

Ashley also noted FDA’s public notification informing industry that clinical and bioanalytical studies conducted by Synchron Research Services and Panexcell Clinical Lab were not acceptable in NDAs and ANDAs because of data-integrity concerns.  Applications using studies conducted by these CROs will need to be repeated, and this has affected more than 100 drug applications.

For questions on any of the topics discussed, please contact the authors or a member of MoFo’s FDA Regulatory + Compliance practice.