21 CFR Part 1 Subpart H - Registration of Food Facilities

What it says

Owners, operators or agents in charge of domestic or foreign facilities that manufacture, process, pack or hold food for consumption in the United States must register the facility with FDA, provide required information including a unique facility identifier, update the registration when required information changes, and renew it every other year. Foreign facilities must designate a United States agent. Some facilities are exempt.

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

What it means in practice

• Registration is the starting point for many other requirements, since the Part 117 rules apply to facilities required to register.
• Registration information must stay current, so changes such as new products or ownership should trigger an update.
• Registration does not mean FDA has approved or endorsed the facility.

What FDA inspectors look for

• Whether the facility is registered and its information is current.
• Whether the correct activities and product categories are listed.
• Whether renewal was completed on time.

Related regulations