What Does FDA’s Reorganized Audit Office Means to You?
(Thursday, January 25, 2024) The FDA announced a major reorganization of its Office of Regulatory Affairs (ORA) which currently leads all FDA audits, litigations, and enforcement actions to reorganize its staff involved with food facility inspections from those involved in drug, biologic, and medical device inspections. The regulated industry needs to be aware of this reorganization, even though the changes might not affect the day-to-day interactions that the industry has with the FDA. The FDA proposed to create a new Office of Inspections and Investigations (OII) led by a new position, the “Associate Commissioner for Inspections and Investigations” directly reporting to the Office of the Commissioner. In addition, there would be a new Deputy Commissioner for Human Foods”. The new offices will be reorganized from within the current ORA. The OII will be focused on inspections (or audits), investigations, and import regulations, while the other compliance functions will be reassigned back to the centers regulating those products. In effect, of the 5100 staff members of ORA, 3600 will stay in OII and 1500 will be reassigned to the centers. The reorganization still needs to go through some administrative steps before becoming final and is expected to be finished this fiscal year. While it is interesting information about the FDA organizational structure, from a practical point of view, don’t expect any changes in the way you deal with your FDA auditors or review divisions. The reorganization does not change any processes related to how to deal with an inspection or queries from the FDA. The reorganization might delay some responses from the FDA as its staff works through the new administrative structure, and its overall impact on the industry the FDA regulates is hard to assess. For now, keep doing what you do, and be responsive to whichever FDA office or personnel contacts you for issues specific to your operations. AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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