FDA to Test Two-Tier Inspections for Food Facilities Subject to Supply Chain Requirements
The Food and Drug Administration seeks volunteers with multiple food processing facilities to participate in a test of a “two-tiered” inspection program for companies subject to supply chain program requirements under human food preventive controls regulations. Under the approach, FDA…
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would first conduct a pre-arranged tier 1 inspection that would examine the company’s written supply chain programs and recall plans, as well as a facility near the company’s corporate headquarters. A second, unannounced tier 2 inspection would then assess compliance with all applicable preventive controls requirements except the written plans reviewed during the tier 1 inspection. Potential benefits of the scheme include decreased inspection time, improved public health protection and greater opportunities for education, outreach and communication between FDA and industry, the agency said. To participate, a company should have two or more domestic registered food facilities that are currently subject to preventive controls requirements and have a centrally developed supply-chain program and recall plan. Participation will be limited to five companies. Requests to participate are due Oct. 31. The Ohio AgriBusiness Association has posted a copy of FDA’s emailed notice to its website.