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FDA Registration Agent
Food Safety Audits
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ESI is an FDA Registration Agent for domestic and foreign manufacturers.

The Processing, Manufacturing, Distribution and Retailing of food in the post 9/11 raises many concerns. FDA and USDA address those concerns in the Bio-Terrorism Act (BT Act)

The short story is the BT Act requires at a minimum one-up and one-down traceability. That means you need programs in place so the Feds can access records within 24 hours or less, in the event of an incident in which they suspect food tampering or weaponizing.

ESI’s Bio-Terrorism services include:
• Food Security System Assessment. An audit of your existing security system. We start with a desk audit of your written plan and continue with an on-site evaluation of the plan’s implementation and maintenance.
• Food Security System Development. This service is modular or turnkey. An ESI Food Security System includes personnel policies, SOPs, emergency response staff and procedures, processing records (development and maintenance), receiving records, receiving procedures, shipping records and procedures. A general traceablilty system. The ESI program includes management and staff orientation.