Logo
SIGN IN

LANGUAGE

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.

sgs-logoFinal 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.

Whoops! Article for GFSR Subscribers Only!


Not a subscriber yet? Sign-up for a FREE subscription today!

Get access to this article, along with our other great content, monthly journal, and more.

SIGN ME UP

Sftharticlefooter R1

Visit our Food Safety Training Platform to Access eCourses, Educational Webinars, and More!

Global Food Safety Resource®

GFSR is a leading educational resource for food safety professionals across the globe. Through our online media channels plus Safe Food Training Hub (SFTH) platform, we deliver perspectives, knowledge and training on the latest food safety trends, regulatory compliance, industry standards, and more.

globalfoodsafetyresource.com | safefoodtraininghub.com
Logos Duallockup

Corporate Head Office

1400 Kingston Rd. Ste. 403
Toronto, ON
Canada, M1N 1R1

Phone: 1-888-437-7395 x105