21 C.F.R. § 1.361 What are the record availability requirements?
Title 21 - Food and Drugs
When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records and other information accessible to FDA under section 414 or 704(a) of the act (21 U.S.C. 350c and 374(a)) must be made readily available for inspection and photocopying or other means of reproduction. Such records and other information must be made available as soon as possible, not to exceed 24 hours from the time of receipt of the official request, from an officer or employee duly designated by the Secretary of Health and Human Services who presents appropriate credentials and a written notice.
Title 21: Food and Drugs
PART 1—GENERAL ENFORCEMENT REGULATIONS
Subpart J—Establishment, Maintenance, and Availability of Records
General Requirements
§ 1.361 What are the record availability requirements?
