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FDA – Food and Dietary Supplements

FSMA Compliance

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FSMA’s preventive controls rule for human food (21 CFR Part 117) requires domestic and foreign food facilities registered with FDA to have a written food safety plan. The plan is prepared by, or under the oversight of, a preventive controls qualified individual (PCQI).

Who Is Obligated?

Food facilities required to register with FDA. Certain small businesses (qualified facilities) and activities subject to the seafood HACCP rule are exempt from some provisions. The US importer also verifies its supplier’s compliance with these rules under FSVP.

What We Do

  • We assess your facility’s coverage under Part 117 and any exemption.
  • We prepare the food safety plan, including the hazard analysis and preventive controls.
  • We adapt your existing HACCP or BRCGS documents to FSMA requirements.

What You Receive

  • Food safety plan
  • Gap and improvement list
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FSMA Food Safety Plan (Preventive Controls) Application

Facility, product, process, and current food safety system details so that we can start preparing your food safety plan under 21 CFR Part 117.

  1. 1 Facility
  2. 2 Products and Process
  3. 3 Current System and PCQI
  4. 4 Submit
1. Facility
Is the facility registered with the FDA? *
Might your company fall under the FDA's "very small business" definition? *

Such facilities (qualified facilities) are exempt from certain requirements. We will assess your status together when reviewing your application.

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

I have a HACCP plan. Is it enough for FSMA?
Not on its own. FSMA’s preventive controls rule requires its own food safety plan; we adapt your existing HACCP or BRCGS documents to these requirements.
What is a PCQI, and does my company need one?
A PCQI is a preventive controls qualified individual. The food safety plan is prepared by a PCQI or under a PCQI’s oversight.
Are small businesses exempt?
Certain small businesses (qualified facilities) are exempt from some provisions. We determine your facility’s status in the scope assessment.

Sources: 21 CFR 117.3; 21 CFR 117.5; 21 CFR 117.126; 21 CFR 117.180; 21 CFR 1.502.