21 CFR 117.7 - Applicability of Subparts C and G to a Facility Solely Engaged in the Storage of Unexposed Packaged Food

What it says

Subparts C and G of Part 117, covering hazard analysis, risk-based preventive controls and the supply-chain program, do not apply to a facility solely engaged in the storage of packaged food that is not exposed to the environment. The facility remains subject to the CGMP requirements, and where the packaged food requires time and temperature control to keep it safe, the facility must establish and implement temperature controls, monitor them, take corrective action when needed, verify them, and keep records.

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

What it means in practice

• A warehouse holding sealed products can avoid the full preventive controls framework, but it still has to meet the CGMP rules.
• Refrigerated or frozen storage brings in a requirement for temperature controls, monitoring and records.
• The exemption is lost if the food is exposed, for example if packages are opened or repacked.

What FDA inspectors look for

• Whether the food stored is truly packaged and unexposed.
• Whether temperature controls are in place, monitored and recorded where needed.
• Whether corrective action is taken and documented when temperatures go out of range.

Related regulations