FDA limits Timeframe for Responding to a 483

When deficiencies are found during an inspection, they are noted in a so-called form 483 (483 is the number of the form used). The report is handed out by the investigator at the end of the inspection. In the past, some firms only responded to parts of these reports or sent an official response with a delay of several weeks.

In a new programme starting on 15 September 2009, the FDA intends to set the timeframe for statements and responses to a 483 to a maximum of 15 business days. It is the aim of this measure to enable the agency to issue Warning Letters more rapidly if necessary. A Warning Letter is issued in case of serious deviations, but also if a written response to the 483 report is considered inadequate.

In the future, if the FDA receives the written response to the 483 within the set period, the response will be reviewed in detail before a Warning Letter might be issued. Should the response arrive later, the Warning Letter can be issued independently of it, and the firm's statement will not be taken into consideration.

The programme is planned to run 18 months. After this phase, the FDA will decide whether the new regulation remains in force unchanged or whether it is modified.

Further information: Docket No. FDA-2009-N-0335: Review of Post-Inspection Responses

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)