The overhaul of the warning letter system was announced by Food and Drug Administration (FDA) Commissioner Dr Margaret Hamburg in a speech to food and drug lawyers last week, with the purpose of speeding the process from the time a company receives an FDA 483 form, which lists inspection observations, to the issuance of a warning letter.
The problem, the FDA says, is that following receipt of a 483 inspection report, many companies respond in writing, explaining what corrective actions they have undertaken or intend to undertake, and some firms submit multiple responses over many months. This can effectively allow some facilities that are in violation of safety standards to continue to operate without warning.
The Federal Register document states: “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.”
Under the new program, companies will have 15 working days to respond to the 483 form, and if a company does not respond during this time, the FDA will send a warning letter.
However, if the agency receives a response in that time, it has said it will “conduct a detailed review of the response before determining whether to issue a warning letter”.
“The purpose of this program is to optimize resource utilization, facilitate the timely issuance of warning letters, and promote prompt correction of violations.”
The notice also clarified that the FDA can issue warning letters at any time, whether or not a company has responded to a 483 form, and that companies are expected to implement corrections to conform to requirements, independent of any response procedure.
The FDA said it will assess the effectiveness of the new program after 18 months and decide whether it will be continued, with or without modifications.