The FDA issues a warning letter when a company has committed a serious violation. It’s the agency's primary method of communication with violators and is the first step to enforcing regulations.
In the case of a health care product manufacturer, this can include (but is not limited to) illegal or deceptive marketing practices or failure to follow Current Good Manufacturing Practices (CGMPs) that insure product safety. The warning letter also provides instructions as to what actions must be taken to remedy the situation and a series of deadlines for notifying the FDA of the company's progress. During this time, the FDA regularly monitors the violator in order to make certain corrective action is being taken. If the company fails to comply, additional steps may be taken.
The FDA may discover violations in the course of its own inspections. Alternatively, violations may come to the agency's attention from the state level. In either case, a warning letter is simply the first step, giving a company the opportunity for voluntary compliance by serving prior notice before further action is taken.
When an FDA field or district office becomes aware of a violation, it submits a warning letter recommendation through the agency's Compliance Management System (CMS). The recommendation must include documentation, which includes details of the violation as outlined in the Establishment Inspection Report (EIR) as well as any written response from the violator.
Warning letters are required by law to be clearly identified as such. The header must include “WARNING LETTER” along with a number identifying the specific case. The letter is sent to the chief executive officer or owner of the company, and a copy is sent to the highest-level manager at the facility where the violation has occurred. Warning letters may be sent electronically, via the U.S. Postal Service or a private courier, and must have some type of documentation of delivery, such as a return receipt.
If, during the initial inspection, the company has promised to take corrective action, this is acknowledged in the letter. The FDA will also request that such action take place within a specific time frame (generally, 15 business days from the date of receipt) or that the company provide a written response. In some cases, a company representative is given an opportunity to meet with FDA officials in order to discuss the matter.
The letter also includes a Warning Statement, informing the violator that failure to address the problem may result in further action by the FDA without advance notice. For pharmaceutical companies and medical device manufacturers, such consequences may include withdrawal of contracts with federal health agencies.