Recalls and Seizures
Recalls can be very disruptive on your business. HTC members have managed numerous product recalls over the years and can be a very effective resource in managing what can be a very large drain on your company's personnel.
By utilizing our Recall Relief services, HTC can work with all parties of the recall planning and execution. We will work with your team by creating an effective Recall Plan, communicating with the FDA and executing product recovery. We will create analysis of the notifications and product recovery activities and provide timely status reports for your company and the FDA.
We will prepare or assist with the preparation of your Recall Close-out report to the FDA.
Seizures are a specialized area of the law that the FDA uses as part of its Enforcement Activities. If you are involved in a Seizure action or you believe the FDA may be planning one, you need to be prepared for the effects on your business.
When a product seizure occurs, you need to have appropriate counsel and you need to have HTC support. We can aide in Crisis Management and the legal issues that may result from a seizure and what steps need to follow such an enforcement action.