Expert: Best Practice Approach to 483s Key to Avoiding Warning Letters

Best practices in writing Form 483 response letters could help manufacturers avoid FDA warning letters, a compliance expert says.

While there are no guarantees, a complete and comprehensive response that explains all corrective actions taken to address the FDA’s concerns can put observations to rest, says Elaine Messa, president of NSF Health Sciences Medical Devices. “If you respond adequately & comprehensively, what more can the agency ask for?” she says.

Companies often make the mistake of forgetting their audience, Messa says. Manufacturers must remember they aren’t just talking to the investigator who conducted the inspection; they’re also talking to compliance directors at the FDA branch office and possibly at CDRH.

The distinction is important because manufacturers need to fully answer all observations in their Form 483 response, Messa says. Using shorthand that assumes the reader knows what was discussed during the inspection might cheat a devicemaker out of a chance to provide context.

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