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Revised recordkeeping guidance

This article was originally published in The Tan Sheet

Executive Summary

"Two subsidiaries share the same facility. Does this regulation require the establishment and maintenance of records when food is transferred from the possession of one subsidiary to the other?" is one of the questions FDA answers in the second edition of "Guidance for Industry: Questions & Answers Regarding the Final Rule on Establishment and Maintenance of Records" published in the Federal Register Nov. 22. The agency will "periodically" update the guidance due to the "large number" of questions it has received regarding the final rule on recordkeeping published by the agency in December 2004 as a result of the Bioterrorism Act. The first edition of the guidance was published in September 2005 (1"The Tan Sheet" Sept. 12, 2005, In Brief). Comments on the rule may be submitted "at any time"...

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