An FDA Warning Letter concerns a violation of the Federal Food, Drug, and Cosmetic Act (FFDCA). FDA warnings come from inspections or investigations that the agency completed. You will read about these topics on this web page.

The FDA defines a Warning Letter as: “ . . .a correspondence that notifies regulated industry about violations that FDA has documented during its inspection or investigations.” An FDA Warning Letter notifies a company that the Agency considers one or more products, practices, processes, or other activities to be in violation of the FFDCA. A Warning Letter is one of the FDA’s principal means of achieving prompt voluntary compliance with the law.

The FDA issues warnings based on its own inspections or on evidence obtained by state personnel.

The Warning Letter is informal and advisory. It does not mean the FDA will take enforcement action. You cannot sue the FDA based on a Warning Letter because it is not a final action.

The FDA expects that most companies will voluntarily comply with the law. The Warning Letter gives them the opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The letter serves to establish “prior notice.”

The FDA has a computer application called the Compliance Management System (CMS). District offices use it to electronically submit Warning Letter recommendations to the FDA Center. All recommendations by the district offices must use the CMS for submitting the:

• Proposed Warning Letter
• Form FDA 483 that supports the alleged violations
• Establishment Inspection Report
• Any written response from the company

As may be expected, the FDA warnings follow a specific format. The components of the Warning Letter are here for you.

• Title: “WARNING LETTER” words at the top of the letter.
• Delivery: Overnight delivery with return receipt requested.
• Addresses: The highest known official of the company and the highest known official of the specific facility where the inspection took place. Districts will send copies of Warning Letters to appropriate state agencies.
• Inspection details: The dates of the inspection, a description of the violation, citation of the section of the law or regulation violated.
• Promised corrections: Acknowledge corrections promised during the inspection.
• Response request: Request corrections and a written response with a specific period, usually 15 working days. The company may have the opportunity to discuss the letter with district officials, or center officials.
• Warning statement: Failure to achieve prompt correction may result in enforcement action without further notices.
• Impact: For certain drug violations, a statement regarding the potential impact on requests for approval of export certificates and drug applications.
• Additional Impact: For device manufacturers a statement about premarket approval applications and requests for Certificates to Foreign Governments will not be granted until the violations are corrected.
• Instructions for response: Instructions stating the response steps and time and documentation necessary.
• Identification of response recipient: Designated district or center official
• Issuer: District director or division director or higher.
• Standard closing text: A verbatim three paragraph closing that asks for prompt action to correct the violations.

A written promise to take prompt corrective action can result in a decision to not issue a Warning Letter. When the agency finds that corrective actions are implemented and adequate, a Warning Letter will not be forthcoming.

There are a bevy of violations that require review by their respective FDA Center. As of November 29, 2001, the FDA must submit all Warning Letters to the Office of Chief Council (OCC) for review.

The FDA and FTC issued their first joint Warning Letter on October 15, 2009. It was to a web site marketing fraudulent supplements. “Cyber” Warning Letters are sent via the Internet to web sites that offer to sell online prescription drugs that may be illegal.

There is no legal requirement for the FDA to issue a Warning Letter before taking enforcement action. The FDA further asserts that there are egregious circumstances when a Warning Letter is not appropriate and immediate enforcement action is.

An FDA Warning Letter is public information. The FDA has a Public Reading Room in Rockville, Maryland. The Freedom of Information Act (FOIA) requires public accessibility to electronic reading rooms. FDA warnings are serious and need your immediate attention.

Written by: Margaret Stenerson

10 4 2010