FDA to Offer New Warning-Letter Process for Food Safety Violations
The Food and Drug Administration (FDA) has announced a new warning-letter system to notify food companies of safety regulation violations. Scheduled to begin on September 15, 2009, the system stems from an effort to speed up the process from the time a company receives an “FDA 483” inspection report to the issuance of a warning letter. It allows companies 15 working days to respond to the 483
form, and if they do not respond during that time, FDA will send a warning letter. If FDA does receive a response in that time, it will “conduct a detailed review of the response before determining whether to send a warning letter.”
According to a Federal Register notice, many companies respond in writing once they get the 483 report by describing completed or ongoing corrective actions or promise of future corrections. “In fact, some inspected establishments submit multiple responses to FDA, sometimes over many months,” states FDA. “Delayed and multiple responses to an FDA 483 have resulted in delays in the issuance of warning letters while these responses are reviewed and addressed. FDA’s timely issuance of a warning letter should help to achieve prompt voluntary compliance and is therefore in the public interest.”
The notice clarified that FDA can issue warning letters at any time, and that companies are expected to implement needed corrections independent of any response procedure. FDA will evaluate the new process after 18 months to decide whether to continue it with or without adjustments. See Federal Register, August 11, 2009.
