US FDA Publishes Final Rule on Record Access for Industries

On 4 April 2014 the United States Food and Drug Administration (US FDA) issued the final rule on record access and is making available two guidance documents (1). One guidance document is for all applicable industries and the other is specifically for small entities.

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. 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.

Records they can access –

Manufacturing: raw materials (ingredients and packaging) receipt, product distribution, product inventory, testing, recall, reportable food, customer distribution lists, complaint and adverse event records.

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: recipes, financial data, pricing data, personnel data, research data and sales data not related to shipping.

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.

References:

(1) U.S. Food and Drug Administration – FDA Issues Final Rule on Record Access Requirements and Announces Guidance for Industry

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