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The Anatomy of a Warning Letter, Part One: A Primer

This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first article is an introduction, if you will, to Warning Letters. The second article will contain actual warning letter excerpts with a recommended strategy to respond to FDA in a compliant and effective manner.

What this Article Contains:

  • Understanding What a Warning Letter Is: Introduction and Factoids
  • Contents of a Warning Letter
  • Warning Letter Model: a Sample

Introduction

A Warning Letter is one of FDA’s principal means of achieving timely voluntary compliance with the Food, Drug, and Cosmetic Act (The Act or FD & C Act – The Law).

When the Food and Drug Administration (FDA) finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer directly. This often comes in the form of a Warning Letter. The letter is emphatic and pointed in nature: the company must correct the problem. In time, FDA then checks to make certain that the company’s corrections are compliant. 

FDA expects that individuals, firms and government establishments will voluntarily comply with the law. When departures are found, FDA gives the organization an opportunity to take voluntary and prompt corrective action before FDA initiates an Enforcement Action (e.g., seizure, injunction to stop continued production or distribution of a violative product, administrative detention, civil money penalties and/or prosecution).

Definitions

Warning Letter. A warning letter is correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other Federal statutes. Warning Letters should be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act.

Medical Device. “…an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, which is - (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”

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