Warning: Don’t Delay Submission of Your 483 Response

August 12, 2009

By Carmelina G. Allis

The FDA has issued a Federal Register notice announcing a program that establishes a timeframe for the submission and agency review of responses to Form FDA-483s before the agency’s issuance of Warning Letters.  This announcement is in line with our prior report regarding the new FDA Commissioner’s promises to intensify the agency’s enforcement program.

After issuance of a 483, it is not uncommon for inspected establishments to submit a written response to FDA describing their intent to correct the observations listed in the 483.  Such responses, however, which can sometimes result in numerous correspondences over a period of many months, generally help delay FDA’s issuance of a Warning Letter.  It has been the agency’s practice not to issue a Warning Letter if the company is not a serious or repeat offender, and the 483 written response appears to indicate that the company has implemented most corrective actions and shows the company’s good-faith effort to comply with FDA’s regulations.  That is, in general, FDA will not issue a Warning Letter until it has completed its review of the company’s 483 response.

That practice, however, will soon come to an end.  As of September 15, 2009, FDA will start a new program where it will allow a company 15 business days to respond to a 483 from the date of issuance of the 483.  If the response is received within those 15 business days, FDA will conduct a detailed review of the response before determining whether to issue a Warning Letter.  If the agency decides to issue the Warning Letter after reviewing the company’s timely response, the Warning Letter will recognize receipt of the response and contain a reply as to the apparent adequacy of the company’s corrective actions set forth in its response.  If FDA receives a 483 response more than 15 days after the 483 was issued, the agency will not likely delay the issuance of a Warning Letter in order to review the 483 response.

These procedures have been prompted by the efforts of Dr. Margaret A. Hamburg, the new FDA Commissioner, to step up the agency’s enforcement program.  Along with those efforts, Dr. Hamburg recently promised that the agency will issue “close-out notices” to those companies that fully correct violations.  This Federal Register notice, however, fails to explain whether FDA will implement such a program, or whether companies should expect to receive such letters after satisfactorily addressing FDA’s observations.

FDA will conduct an assessment of this program after 18 months, and will then decide whether to implement it permanently.  The announcement fails to identify the criteria that the agency will evaluate that will serve as indicators that the program has been successful.  The stated goal of the program is to facilitate the agency’s timely issuance of Warning Letters.

Categories: Enforcement