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The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies

This is the second of two articles dealing with the FDA Warning Letter, in which we’ll look at actual letter excerpts with recommended strategies to respond to FDA in a compliant and effective manner. As discussed in the prior article (See BONEZONE, March 2012), when FDA finds that a manufacturer has significantly violated FDA regulations, it notifies the manufacturer. Responsible officials at regulated manufacturing sites have a legal duty to implement measures to ensure that their products, facilities and operations are in compliance with the law.

When FDA determines that a product is or may become adulterated or misbranded, several actions may be taken, e.g. seizure or detention of a product, injunction of the firm and/or responsible individuals; prosecution of the manufacturer and/or responsible individuals. The actions vary depending upon the degree of danger to the public or willingness of the manufacturer to correct violations.

A Warning Letter may be issued instead of immediately seizing product or obtaining an injunction. The Warning Letter contains a formal advisory that specific sections of the law have been violated and, unless corrective action is taken, FDA is prepared to impose legal and/or administrative sanctions. Unless otherwise indicated, within 15 working days of receiving a Warning Letter, a formal response should be made to FDA.

The following sample includes strategic and tactical steps that you might take in correcting issues following a Warning Letter, in preparation for (possibly) another inspection or ongoing updates to FDA with corrective action(s). The sample includes several sections of the Food, Drug, and Cosmetic (FD&C) Act commonly used in misbranding or adulteration charges. (In this reprint, key words are bolded for emphasis.)

Sample Warning Letter



Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration


10903 New Hampshire Avenue
Silver Spring, MD 20993

December 23, 2011
Via United Parcel Service
President and CEO
Company X, Inc.
Main Street
 xxxxxxxxxx, , USA

Dear Ms. xxxx:

During an inspection of your firm located in xxxxxxxxxxxxxx on September 13–16, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures xxxxxxxxxxxxx, and xxxxxxxxxxxxxxxxxx, Class II Medical Devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.