• How to Respond When FDA Knocks: What Happens When You Say No?
  • September 12, 2013 | Authors: Kelley Connolly Barnaby; Cathy L. Burgess
  • Law Firm: Alston & Bird LLP - Washington Office
  • Two months ago, the Food and Drug Administration (FDA) issued a Draft Guidance entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” (“Draft Guidance”). Congress required FDA to issue this guidance within a year of the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA), which strengthened FDA’s authority regarding inspection refusals, so that now delaying, denying, limiting or refusing to permit inspection causes a drug to be adulterated. 21 U.S.C. § 351(j) (a drug is adulterated if “it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment” where the owner has refused to permit entry or inspection).