A public facing FDA Warning Letter Database exists regarding manufacturers that commit violations of U.S. Food and Drug Administration (FDA) regulations. Recently, this database began flagging organizations for COVID-19 related violations. Specifically, this database captures warning letters that the FDA previously sent out to implicated manufacturers. Issues that trigger a warning letter may include poor manufacturing practices, false product claims, or inaccurate directions for the use of a product.
Streamline Verify has been screening clients against this database and would like to draw attention to the FDA’s guidance to avoid COVID19-related violations in their new COVID-19 pages: Frequently Asked Questions and Guidance Documents for Industry, FDA Staff and Other Stakeholders.
Notably, a new issue coming up repeatedly in the database’s subject header is related to Health Fraud, namely Unapproved and Misbranded Products Related to Coronavirus Disease 2019. Some products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. Others are violating the introduction of products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
As of today, the FDA Warnings Letter Database has excluded 51 entities due to a COVID-19 related concern. A required correction plan with directions and time frames are included in letter.
There is a lag time and the letter in the database may not be a timely reflection of the current regulatory status of the letter recipient. Upon notation from the manufacturer of the corrective actions, next the FDA will confirm the corrections made are sufficient. The letters may not contain regulatory information between the FDA and the letter recipient that occurred subsequently to the letter’s original sent date.
For more information about this database or FDA agency records, please see the page How to Make a Freedom of Information Act (FOIA) Request. As of 3/12/2020, to ensure timely logging, the FDA is asking that all requests be made via their online portal rather than by mail, fax, or courier.