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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Warning Letters: Roadmap to Corrective Action: Facilities should understand the importance of this "early-warning" message from FDA

Facilities should understand the importance of this "early-warning" message from FDA.

If your MQSA inspection reveals Level 1 findings, the most serious noncompliance with MQSA standards, a repeat of a Level 2 finding, or a pattern of continued violations of various types, you could receive a Warning Letter from the Food and Drug Administration (FDA). A Warning Letter is a written communication from FDA notifying a responsible individual, firm, or facility that the agency considers one or more products, practices, processes, or other activities to be in violation of the laws that FDA enforces. The Warning Letter states that the failure to take appropriate and prompt action to correct and prevent any future repeat of the violations noted in the Warning Letter may result in an administrative or regulatory action. Although serious noncompliance is a catalyst for a Warning Letter, a Warning Letter is informal and advisory. The issuance of a Warning Letter embraces the FDA policy that, when consistent with the agency's public health responsibilities, it is appropriate to afford individuals, firms, and facilities an opportunity to take appropriate and prompt voluntary corrective actions prior to the initiation of an enforcement action.

Mammography facilities are just one of several industries that are subject to a Warning Letter if found to be in violation of laws administered by FDA. A Warning Letter is considered a public record and is posted on FDA's website for public viewing. Therefore, Warning Letters are one of FDA's principal means of achieving prompt, voluntary compliance, offering recipients a chance to submit a plan of correction so that enforcement measures can be avoided. A noncompliant mammography facility, for example, could expect to receive a Warning Letter from one of FDA's field offices detailing the problems found during an inspection and steps that it needs to take within 15 business days of receipt of the letter.

A facility that fails to respond to a Warning Letter or to correct problems promptly may be re-inspected by FDA at a cost to the facility of $878. The facility also may be subject to an enforcement or administrative action that could include a directed plan of correction, suspension or revocation of its certificate, civil money penalties, an injunction, and other regulatory or administrative actions to ensure that it corrects the violation(s).

Fortunately, most facilities never find themselves in this situation. "Less than 50 percent of facilities have any inspection findings and less than 5 percent of all facilities are issued a Warning Letter," reports Mike Divine, MQSA Compliance Expert with FDA. "And of those, most never have compliance problems after that."