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Letter of applications

FDA letter of applications documented during its inspections or investigations.

While the FDA generally determines violations through its own inspections, they can also issue one based on evidence from state personnel. The FDA considers a warning letter informal and advisory. It communicates the agency’s position on a matter, but does not commit the FDA to an enforcement action. The FDA expects most individuals, firms, and government establishments to voluntarily comply with the law. When the FDA observes a deviation from acceptable practice, they give the organization an opportunity to take voluntary and prompt corrective action before it initiates an enforcement action. The warning letter must have the words «WARNING LETTER» at the top.

The delivery mode is stated on the Warning Letter. The FDA addresses the warning letter to the highest known official in the firm that owns the inspected facility, and sends a copy to the highest known official at the specific inspected facility. If the FDA expects a separate response from other officials, they may included their addressees. The warning letter includes the inspection dates and a description of the violating condition, practice, or product in brief but sufficient detail to provide the respondent the opportunity to correct the matter. It cites the section of the law and, where applicable, the regulation violated.

Unlike the Form FDA 483, the warning letter cites regulatory references for of violation. The warning letter acknowledges corrections promised during the inspection, or that the organization provides to the district in a written response. Letter Warning Letter requests corrections and a written response within a specific period after receipt of the letter—usually fifteen applications days. The district, at its discretion, may offer the recipient an opportunity to discuss the letter with district officials or, when appropriate, with center officials. The Warning Letter includes a statement that warns that failure to promptly correct the matter may result in an FDA enforcement action without further notice. It may include examples of such actions, but makes no commitment that the FDA will take these actions.

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Federal agencies are advised of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. The Warning Letter specifies a designated district or center official to whom the organization must address their response. The Warning Letter identifies the entity that issued it—the district director, division director, or higher agency official. For drug Warning Letters, the information in the above sections 1.

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist . You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that comply with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

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