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Are You Ready for FDA Inspection Changes?

Posted by IFCO Systems
March 16, 2017

FDA inspections are changing in the wake of the Food Safety Modernization Act, and experts such as FoodIndustry Counsel LLC and AIB international are encouraging all FDA-regulated facilities, including foreign operators exporting into the United States, to review their inspection programs to ensure readiness for their next FDA inspection. FoodIndustry Counsel has nearly 20 years of experience as FDA lawyers, and a client base comprised exclusively of food industry clients. The firm cautions site managers to expect thorough facility inspections and record reviews, as well as comprehensive microbiological sampling of food processing equipment, ingredients as well as finished products. Every registered food facility in the U.S. can expect an onsite FDA inspection within the coming years, it advises.

In order to help registered operations prepare for the arrival of FDA inspectors, Shawn Stevens, founder of Food Industry Counsel, has prepared a free FDA INSPECTION CHECKLIST to help not only make adequate preparations before the inspection begins, but in also better managing the the inspection process as it happens and in best responding to any FDA criticisms after the inspection is over.  “With FDA’s aggressive food safety enforcement posture, it is now more important than ever to be prepared,” Stevens writes.

AIB International encourages all FDA-regulated to download the FDA Inspection Checklist to receive details and advice pertaining to each item. AIB also offers an FDA Preparedness Inspection, designed to assist food facility operators in better preparing for the ne FDA inspection process. In 2016, the company updated five of its Consolidated Standards for Inspection, with a goal of helping operators minimize their food safety risks.

Farm Inspections Beginning in 2018

Meanwhile, fruit and vegetable growers are about to “experience a new layer of government involvement beginning in 2018,” The Packer recently reported. That’s when government inspectors will start performing inspections at U.S. farms with sales greater than $500,00 annually. (Inspections at farms with sales in the $250 - 500K range begin in 2019). During fiscal year 2018. FDA intends to collaboratively create and trial an initial farm inspection model.

Many states intend to offer education, outreach and inspection services to farms, funded by the FDA, according to The Packer report, noting that traditionally, the FDA has only visited farms linked to an outbreak. There has been a past practice of the FDA utilizing state inspectors, for example at milk plants and at operations governed by federal seafood regulations.

“I think if it is done correctly, it will absolutely be better for the produce industry (Having state inspectors) than having the FDA guys do it, because at least you will get people who are inherently more familiar with the produce industry than (FDA officials) who have spent their life as a drug inspector,” David Acheson, former FDA official and founder and CEO of The Acheson Group, told The Packer. He also stressed the importance of consistent training of inspectors across the country to ensure consistent enforcement, and as a result, a more equitable produce market.

While only five states have applied to the FDA just for education and outreach funding, most other states have also asked for money to perform inspections. FDA is making changes to its original announcement to allow those five states to also request inspection funding. 

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Topics: Food Safety