21 CFR 117.201 - Modified Requirements That Apply to a Qualified Facility

What it says

A qualified facility, generally a very small business, is exempt from the hazard analysis and risk-based preventive controls requirements of Subpart C and the supply-chain program requirements of Subpart G. It must instead submit an attestation to FDA, either that it has identified potential hazards and is implementing and monitoring preventive controls, or that it complies with applicable non-federal food safety law, along with an attestation that it meets the criteria for a very small business. The attestation must be renewed and updated at set intervals, and the facility must keep records to support it.

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

What it means in practice

• A qualified facility is still subject to the CGMP requirements of Subpart B.
• The attestation is a formal statement to FDA, so it needs to be backed by documentation.
• The status can change with the business, so it should be reviewed when sales or ownership change.

What FDA inspectors look for

• Whether the facility meets the definition of a qualified facility.
• Whether the attestation was submitted and is current.
• Whether records support the statements made in the attestation.

Related regulations