FDA Warning Letter Response and Remediation

Company Situation

A mid-sized drug company received FDA 483 after routine GMP inspection. The company responded but subsequently received a Warning Letter. This company was not sure how to best approach the FDA after receiving the Warning Letter, especially that don’t have any additional information or data to add to their first response to form 483.

The company approached Global Regulatory Partners to help them handle the situation.

GRP Solution

A mid-sized drug company received FDA 483 after routine GMP inspection. The company responded but subsequently received a Warning Letter. This company was not sure how to best approach the FDA after receiving the Warning Letter, especially that don’t have any additional information or data to add to their first response to form 483.

The company approached Global Regulatory Partners to help them handle the situation.