The final rule is exactly the same as the interim final rule published 23 February 2012 in Safeguards 03812. The Guidance for Industry: FDA Records Access Authority under Sections 414 and 704 of the Federal Food, Drug, & Cosmetic Act has minor changes since it was last published 23 February 2012. The Guidance for the industry: What you need to know about Establishments and Maintenance of Records; Small Entity Compliance Guide replaced the guidance published December 2004.
The US FDA may have access and copy records if they have a reasonable belief that the food or feed is likely to be adulterated and presents athreat of serious adverse health consequences or death to humans and animals.