Final Rule and Guidance on Record Access Requirements
The final rule is exactly the same as the interim final rule published 23 February 2012 in Safeguards 03812 http://newsletter.sgs.com/
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 a threat of serious adverse health consequences or death to humans and animals.
Records they can access –
Records they do not have access to –
From Farms, from restaurants, from operations exclusively under the United States Department of Agriculture Food Safety Inspection Service jurisdiction:
Generally records are to be maintained for at least 2 years. In case of failure to produce the records or produce them within 24 hours, the US FDA can suspend the food facilities registration, issue an administrative detention, seize the food/feed, issue a recall or issue an injunction against the firm.
(1) U.S. Food and Drug Administration - FDA Issues Final Rule on Record Access Requirements and Announces Guidance for Industry http://www.fda.gov/
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