Tag Archives: 483 observations dietary supplements

FDA Enforcement: Foods (FSMA)

Recent data* from FDA reveal that the food inspection program under new FSMA cGMP and FSVP regulations is ramping up.  The chart shows food inspection citations on 483’s issued by FDA for FY 2015-2018 (FY’18 is partial thru 6/7/18).  During 2015 and 2016 the split was largely between foods (21 CFR 110) and dietary supplements (21 CFR 111).  Since FY 2017, FDA has increasingly issued citations under 21 CFR 117 (FSMA food CGMPs) and 21 CFR 1.5xx** (FSMA, specifically FSVP, the foreign supplier verification program regulation) while inspections under the old 110 food CGMPs are rapidly declining.

** UPDATE: Oops! There is a mistake in the key to this chart, the light green columns are for 21 CFR Part 1, Subpart L (aka 21 CFR 1.500 thru 1.514)

To learn more about this topic, and see updated FDA data, you may like to attend my presentation at SupplySide West in Las Vegas, on Thursday, Nov. 8 (2-4 pm)

Are You Prepared for a FSMA Audit?

The Food Safety Modernization Act (FSMA), which became law in 2011, increased the regulatory requirements that food, beverage and supplement manufacturers must follow to ensure food safety. By July 2017, the law was applicable to most food and beverage makers and FDA began actively enforcing rules and inspecting facilities based on varying implementation timelines. In this session attendees will learn how FSMA affects their business, suppliers, co-manufacturers and importers; compliance challenges and strategies; and best practices for preparing and passing a FSMA audit.

Details and Registration

*Data Source: FDA.gov, accessed 6/26/2018