FDA 'Program Alignment' Means Inspections Consistency To Supplement Industry
This article was originally published in The Rose Sheet
Reports are common about ORA officials not being knowledgeable about the agency's supplement manufacturing and marketing regulations or familiar with the commodity of dietary supplements, but relying on drug or food product manufacturing regulations when they inspect supplement facilities.
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Some stakeholders complained FDA inspectors unfamiliar with Part 111 inappropriately held supplement firms to drug or food product manufacturing regulations, but the agency's assignment of inspectors with greater expertise on the regulations could be turning up compliance problems in the sector that other ORA officials might have missed.
The number of facilities inspected for compliance with supplement GMP requirements is increasing annually as the agency meets targets set by FSMA, according to data the American Herbal Products Association presented during a webinar.
'Program Alignment' Falls Into Place: Everything You Need To Know About US FDA's New Inspectional Approach
For the medical device industry, FDA's five regional offices – Pacific, Central, Northeast, Southwest, Southeast – will be replaced by three distinct divisions across the US encompassing 20 FDA district offices on May 15. Check out the latest US map from the agency showing where the device divisions will be located, and find out what your firm will be facing at its next facility inspection.