If the FDA issues you a 483 inspection observation or warning letter, Regulatory Compliance Associates® Inc. 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. We can also provide independent oversight of your operations during the remediation efforts to help mitigate the impact to ongoing business.
Our list of services and programs to help with remediation efforts include:
- 483 Response
- Warning Letter
- Consent Decree
- Import Bans
- Notified Bodies
- Independent Third Party Oversight