Regulatory Strategy: FDA-483 and Warning Letter Responses

Begin with the end in mind… just as a building follows a blueprint.

Heading off an enforcement action can only happen if your response is compelling to the agency. QualityHub’s understanding of FDA’s processes and expectations, along with the Industry’s best practices, will provide you with the right guidance on how to best respond to FDA. Each situation is unique, yet there are critical items that need to be included in all responses, regardless of the situation.

In parallel to the FDA-483 and Warning Letter Responses, there are several other activities that are crucial. QualityHub can also assist you with:

  • Analysis of current and past FDA-483s, internal and external audits
  • Development of Corrective Action (Compliance) Plans that will be effective from a compliance perspective, but will also be consistent with the needs of your business
  • Implementing and executing the Corrective Action (Compliance) Plans
  • Providing periodic updates to a FDA-483 or Warning Letter
  • Meetings with FDA as necessary to help resolve enforcement actions

 

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