Guidance for Industry: What You Need To Know About Establishment, Maintenance, and Availability of Records Small Entity Compliance Guide

Link

https://www.fda.gov/media/88292/download

Author

U.S. Food & Drug Administration

Source

U.S. Food & Drug Administration

Summary

A guidance publication explaining which records producers are required to maintain, how long they must be held, which records are exempt, who must keep records, and how the FDA will go about requesting records.

Year

2014

Language

  • English

PCHF Category

  • Complying with the PCHF Rule » Records

Keywords