FDA Enforcement Defense

Prompt Response, Skilled Defense in FDA Enforcement

For manufacturers, importers or distributors of OTC Drugs, natural foods or supplements, notice of an FDA inspection represents the first of a series of events that could have serious consequences for your company. To learn how your company can benefit from the advice of attorneys who know how to respond to FDA Inspectional Observations and Warning Letters, contact the New York law firm of Ullman, Shapiro & Ullman.


There is a new urgency with regard to presenting your response to FDA Form 483 report of inspectional observations. Until recently, there was no established deadline for companies in receipt of an FDA Form 483 to submit a response to FDA’s, though FDA’s receipt of such responses tended to delay its issuance of a Warning Letter, the first step in the Agency’s formal enforcement process. Since September 2009, however, any company receiving a Form 483 must issue a response to FDA’s inspectional observations within 15 business days if it wants FDA to consider that response when deciding whether to issue a Warning Letter.


At Ullman, Shapiro & Ullman, our lawyers understand that the best way to minimize the risk of seizure or recall of nutritional products and supplements is to work constructively with FDA at every stage of the inspection and response process. We work with clients located throughout the United States on this process.

Our law firm emphasizes the importance of speed and efficiency, both to serve the needs of our clients and to assure regulatory agencies of our interest in a prompt and complete resolution. FDA’s new policy of encouraging a company’s prompt response to inspectional observations of violations puts a new premium on your legal team’s ability to present your company’s strongest case at an early stage of the enforcement process. That is a challenge that Ullman, Shapiro & Ullman is well accustomed to meeting.

Comprehensive Client Service in FDA Enforcement Defense

Our attorneys can help your company respond to notices of inspection, denials of “May Proceed” releases, Form 483 reports, Courtesy Letters and Warning Letters. Our goal is to make sure that the violations noted in a Form 483 do not find their way into a Warning Letter, which can represent the first step toward removing your product from the market.

To learn more about our ability to respond quickly and productively at any stage of an FDA inspection or enforcement proceeding nationwide, contact Ullman, Shapiro & Ullman in New York.