General FDA Warning Letters

If the FDA determines that a manufacturer has materially violated FDA regulations, the FDA notifies the manufacturer. This notification is often in the form of a warning letter.

Warnings identify violations such as: poor production practices, problems with claims about what a product can do, or incorrect instructions for use. You may search FDA issued warning letters.

The letter also explained that the company needed to resolve the problem and provided guidance and a time frame for the company to inform the FDA of its corrective action plan. The FDA will then assess whether the company's adjustments are appropriate.

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The issue defined in the FDA warning letter may have been the topic of successive interactions between the FDA and the receiver of the letter, which may have altered the regulatory status of the issues discussed in the letter.

Warning letters for drug marketing and promotion (and untitled letters for pharmaceutical companies)

These letters, sorted by month, only cover marketing, communications, and drug alerts. Some emails have been edited to remove sensitive information. Cyber emails are sent electronically over the Internet to websites offering prescription drugs online that may be illegal.

The letters warned the owners of this website that they might be involved in illegal activities and notified them of laws governing the sale of prescription drugs.