21 CFR 117 Subpart A - General Provisions

What it says

Subpart A is the foundation of 21 CFR Part 117. It covers who and what the rule applies to, the definitions used throughout, the qualifications required of the people who manufacture, process, pack or hold food, and the exemptions and modified requirements for certain facilities and activities. It also makes clear that failing to follow the rule can cause food to be considered adulterated under the FD&C Act.

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

What it means in practice

• Every other subpart depends on these opening provisions, so a facility first has to work out which parts of Part 117 apply to it and which exemptions or modified requirements, if any, it can rely on.
• The definitions have specific meanings in the rule that can differ from everyday use, for example for a hazard requiring a preventive control or a ready-to-eat food, so food safety plans should use them consistently.
• Personnel qualifications apply to everyone who manufactures, processes, packs or holds food, which links training records directly to compliance.

What FDA inspectors look for

• Whether the facility has documented why it is subject to each part of the rule, including the basis for any exemption it claims.
• Whether personnel have the education, training or experience for their assigned duties, with records to show it.
• Whether the facility plans and procedures use the defined terms of the rule correctly.

Related regulations