When FDA conducts an inspection of a regulated facility, it will conclude the inspection a discussion with the facility’s management – most often the senior manager at the facility. 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 inspector’s observations. Depending upon the severity of the objectionable conditions, the FDA Inspector may issue an FDA Form 483, outlining the observations that are most objectionable. After the inspection is concluded, the FDA may issue a “Warning Letter” to the firm regarding the violations observed during the inspection. Warning Letters are public documents and are published on FDA’s Internet site.

Under other circumstances, where violations observed during the inspection are worthy of note, but there is no 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 Warning Letters and Untitled Letters. These responses must address the agency’s concerns and should include manufacturing, storage, processing or operating procedural changes undertaken based upon the inspection.

FDAImports.com consultants and affiliated attorneys assist firms (foreign and domestic) in responding to FDA Warning and Untitled Letters and 483s.