FDA Enforcement | Warning, Untitled Letters & 483s

When FDA conducts a facility inspection, it will conclude the inspection by having a meeting with the facility’s management discussing the inspector’s observations. During this discussion, the FDA Inspector may identify a series of objectionable conditions observed during the inspection and the inspected firm has the ability to ask questions regarding the observations. Depending upon the severity of the problems FDA identified, the Inspector may issue an FDA Form 483, outlining the most objectionable observations. FDA expects the inspected facility to respond to an FDA Form 483 in writing identifying the steps taken (or that will be taken) to adequately address the observations identified in the form.

If FDA is not satisfied with a facility’s 483-response, or if the violations are of a significant nature relating to consumer safety, the FDA may issue a “Warning Letter” to the firm regarding the violations. Although anyone can request a copy of a 483 from FDA and receive it, FDA Warning Letters are public documents from the point they are issued and are published on FDA’s Internet site.  FDA’s Warning Letters will always recite the fact that the violations noted in the letter are not intended to be an all inclusive list of problems discovered at the facility.  In addition, FDA will set a time within which the facility must respond to the warning letter in writing.

Under other circumstances, where violations FDA observed are noteworthy, but there is less clear authority for the FDA to regulate a specific aspect of a firm’s processes, FDA may issue an Untitled Letter.

FDA will expect a written response to FDA 483s and FDA Warning Letters and Untitled Letters. These responses must address the agency’s concerns and should include any changes the facility has implemented in its manufacturing, storage, or operating processes based upon the inspection.

FDAImports.com, LLC assists FDA-regulated manufacturers, importers and distributors assess the validity of FDA 483s and FDA Warning Letters and Untitled Letters and helps in correcting FDA’s observations and drafting responses to FDA’s concerns.  FDAImports.com, LLC can also place highly qualified former FDA inspectors and compliance officers inside of a client’s facility to assist with corrections or assess whether FDA’s objections are even warranted.