If the FDA issues you a 483 inspection observation or sends you a warning letter, RCA can assist in developing a response that will be accepted by the Agency and be realistic for your organization to execute. We can prepare a strategy and implementation program to help remediate the observations as well as develop a comprehensive proof book. RCA can also provide independent oversight of your operations during the remediation efforts to help mitigate the impact to on going business.
Every situation is different and the program’s regulatory response plan may include aggressive but realistic milestones, as well as supporting tasks, and task dependencies. Our consultants have experience in FDA-regulated industries and have the expertise to assist you with:
- FDA
- Support with preparing for and attending FDA meetings
- Responding to US FDA communications
- Assistance with drafting responses to:
- 483 Observations
- Warning Letters
- Consent Decrees
- Other compliance and enforcement related activites
- Import Bans
- Notified Bodies
- Independent Third Party Oversight and Interim Controls
