About FDA Warning Letters
When FDA identifies what it believes are significant violation(s) of federal requirement(s), FDA notifies the appropriate party. This notification is often in the form of a Warning Letter. The Warning Letter identifies the concern(s), such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter provides an opportunity for the company or individual to address FDA’s concerns and requests a response with a certain timeframe. This response could consist of plans for correction and FDA would then check to ensure that the corrections are adequate. To the extent the company or individual disagrees with the FDA’s concerns, the company or individual has the opportunity to supply FDA with its reasoning and supporting information. These communications and other actions by FDA and/or the recipient of the letter may change the regulatory status of the issues discussed in the letter. (Read more)
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