21 CFR 117.251 - Circumstances That May Lead FDA to Withdraw a Qualified Facility Exemption

What it says

FDA may withdraw the exemption for a qualified facility if it determines this is necessary to protect public health, based on an active investigation of a foodborne illness outbreak that is directly linked to the facility, or on conditions or conduct at the facility that are material to the safety of the food and are associated with a potential foodborne illness outbreak. The facility is notified, may respond, and can request a hearing, and the withdrawal can be reinstated.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Small business status is not a permanent shield, and an outbreak or serious conditions can bring the full rule into force.
• A facility that receives a notice has a process to respond, and a defined time to do so.
• Good basic practices reduce the chance of ever reaching this point.

What FDA inspectors look for

• Whether conditions at the facility pose a risk linked to illness.
• Whether the facility has responded to previous findings.
• Whether it can show it controls the hazards identified.

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