FDA Warning Letter Close-Out Letter

“Is there an FDA close-out letter indicating a Warning Letter is lifted”, is a very common question concerning companies who receive warning letters.
Usually the only want a company use to learn that the Warning Letter was lifted was if the FDA provided an export certificate or a 510(k) clearance or PMA approval. For foreign companies automatic detention without samples is lifted and shipments are allowed to enter the USA.

Well, that was then this now. Warning Letters issued as of September 1, 2009 will, no could have a close-out letter if the violations in the Warning Letter have been adequately addressed.

Warning Letter Close-out Letter
A Warning Letter close-out letter ("close-out letter") will not be issued based on representations that some action will or has been taken. The corrective actions must actually have been made and verified by FDA.

The district or center that issued the Warning Letter should issue a close-out letter for Warning Letters issued on or after September 1, 2009, if the violations in the Warning Letter have been adequately addressed, and the following conditions have been met:
a. The firm replied to the Warning Letter with sufficient information to demonstrate that any listed violations have been adequately corrected; or
b. A follow-up inspection shows that implementation of the corrective actions was adequate, or, based on other verified, appropriate and reliable information, FDA determines that the follow-up inspection is not needed; and
c. The follow-up inspection (or other appropriate and reliable information) does not reveal other significant violations.
The issuing office will evaluate the firm’s response to the Warning Letter.

Where the district is the issuing office, the following procedure should be followed prior to issuance of a close-out letter. If the district performs an inspection to verify correction, the district may, but need not, ask the center whether it has a comment or objection prior to issuing a close-out letter. If the district decides not to inspect to verify correction, and the Warning Letter required center concurrence, the district will ask the center, via CMS, whether it has a comment or objection prior to issuing a close-out letter. The center will enter any comments or objections to the issuance of a close-out letter (i.e., FDA’s conclusion that the firm’s corrective actions are adequate to address the violations contained in the Warning Letter), via the center documents tab in CMS within 30 working days. If the center requests more time, an additional 30 working days should be granted. At the end of the 30 (or 60) working day period, the district will review the center’s comments or objections, if any, providing deference to the center in areas of the center’s expertise, and, where the center has provided comments or objections, will issue the close-out letter only if consensus is reached with the center.
Districts or centers should issue close-out letters within a total of 65 working days of having the necessary information upon which to make a decision. Use the model "close-out letter" in Exhibit 4-2. The issuing district or center is responsible for ensuring that a PDF copy of the final, signed close-out letter is added into CMS.

A close-out letter does not relieve the recipient from their responsibility for taking all necessary steps to assure sustained compliance with the Act, and all other applicable requirements. If a subsequent inspection reveals problems with the adequacy or sustainability of the corrections that were taken in response to the Warning Letter, such violations would be considered serious. If FDA observes violations during subsequent inspections or through other means, we may take enforcement action without further notice.

The issuing district or center will ensure that FDA posts a notice on http://www.fda.gov/foi/warning.htm when a close-out letter is issued.

For more information on Warning Letter Close-out letters, contact mdi at, info@mdiconsultants.com and reference Close-out letters.

If you are present involved with a W/L corrective action and/or are fearing you may be the recipient of an FDA W/L please contact us and we would possible be able to assist you to prevent the issuance of this serious regulatory action. We can be reached at info@mdiconsultants.com and reference W/L