[Code of Federal Regulations] [Title 21, Volume 2] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR107.280] [Page 199] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED PART 107--INFANT FORMULA--Table of Contents Subpart E--Infant Formula Recalls Sec. 107.280 Records retention. Each manufacturer of an infant formula shall make and retain such records respecting the distribution of the infant formula through any establishment owned or operated by such manufacturer as may be necessary to effect and monitor recalls of the formula. Such records shall be retained for at least 1 year after the expiration of the shelf life of the infant formula. (Collection of information requirements in this section were approved by the Office of Management and Budget under OMB control number 0910-0188)