Navigate US FDA food safety regulations including FSMA, 21 CFR Part 117 (Preventive Controls), FSVP (Foreign Supplier Verification Program), facility registration, and FDA import alerts.
Boston's food sector includes seafood, specialty manufacturers, and high-tech food labs across the Greater Boston biotech corridor.
U.S. Food and Drug Administration (FDA)
Massachusetts Department of Public Health — Food Protection Program
Boston Public Health Commission
When you engage Iyarkai for fda / fsma support in Boston, we map every requirement back to the specific regulator most likely to inspect or audit your facility — so you spend less time guessing and more time building a compliant operation.
Iyarkai Scientific Consultation is Boston's trusted partner for fda compliance (usa). As New England's premier food and biotech hub, Boston is home to a growing number of food manufacturers, processors, importers, and exporters who rely on expert food safety compliance to access domestic and international markets. Our experienced consultants bring hands-on regulatory knowledge - including CFIA, SFCR, FDA FSMA, and leading GFSI certification schemes - directly to your Boston facility. Whether you need to develop your first fda compliance (usa) or strengthen an existing program ahead of a regulatory inspection or retailer audit, Iyarkai delivers measurable results.
Book a free 30-minute consultation with an Iyarkai fda compliance consultant serving Boston.
Contact Us TodayBoston-area food companies — from seafood processors on the harbor to the region's dense cluster of food-tech and better-for-you CPG startups — face FDA oversight that differs sharply by product category. Seafood firms operate under the FDA Seafood HACCP regulation (21 CFR 123), while most other manufacturers fall under FSMA's Preventive Controls for Human Food. Getting the category right determines the entire structure of your food safety plan, your required training, and what an FDA investigator will ask for at inspection.
Seafood processors are exempt from the FSMA Preventive Controls rule specifically because 21 CFR 123 already mandates HACCP. You need a HACCP plan built on the FDA Fish and Fishery Products Hazards Guide, with a trained HACCP individual. We build and validate these plans and deliver the required training.
The investigator verifies facility registration, reviews your written food safety plan and monitoring records, walks the plant for GMP compliance (21 CFR 117 Subpart B), and may collect samples. We run mock inspections so your team practices producing exactly the records FDA asks for.
Compliance with the U.S. FDA's Food Safety Modernization Act (FSMA) including Preventive Controls, Foreign Supplier Verification, and FDA registration requirements.
4 to 12 weeks depending on facility scope and FSMA rules in scope.
FDA / FSMA