RealTime FDA™

In the event of FDA-related issues during customs clearance or distribution after export to the U.S., Provision’s U.S.-based regulatory experts respond in real time—helping to resolve issues quickly and minimize delays, refusals, or penalties.

This level of localized, immediate support is a core capability that distinguishes Provision apart from other consulting firms that do not maintain on-the-ground U.S. regulatory response capabilities.

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• Review FDA Notices (e.g., Notice of Action, Import Refusal) and explain the cause and implications.

• Advise on Corrective Actions to resolve the issue efficiently based on FDA’s findings.

• Communicate with FDA Officers by phone or email to clarify issues and confirm next steps.

• Submit Clarification or Appeal Requests if the FDA’s action appears unreasonable or unclear.

• Coordinate with U.S. Importers, Brokers, or Distributors to ensure swift on-the-ground response.

• Assist in Responding to FDA-Related Document Requests from Retailers or Buyers (e.g., Registration status and listing numbers, etc.)
   

1. This service is included free of charge for 6 months with any of our MoCRA services.

2. To extend coverage for an additional 6 months, please contact us to purchase the extended service separately.

3. If any additional regulatory actions are requested by the FDA—such as facility registration, label revisions, or product testing—those services will be billed separately.