Emergency Regulatory & Compliance Assistance
Is the FDA coming to perform an audit next week?
Did the FDA just show up unannounced?
Did you just discover a systemic adverse event?
Are you implementing a Product Recall?
How do you handle a 483 or a Warning Letter?
Do you need help with your Health Hazard Evaluations (HHE)?
Do you know you have 15 days to answer a Warning Letter or a 483 if you want the FDA to consider your answer?
How a company responds to an FDA Warning letter or even a 483 notice can make the difference between a quick resolution and a long expensive remediation program. It is critical to respond to each situation carefully and thoughtfully.
Recalls, audit actions, and MDR filings must be handled properly and proactively to ensure patient safety and minimize any potential damage to a company’s reputation. An inadequate response to a finding or a misunderstanding during an audit can lead to a warning letter or a freeze on all submissions at the FDA, eliminating the ability to release product to the market. Even a change to regulations or guidance documents can lead to unanticipated removals, corrections, or involuntary recalls. Call us early in the process so that we can provide the greatest value to your firm.
MEDIcept personnel have been in your shoes. We have been on the front line with investigators, spoken to the FDA to delay audits, written corrections, and have had 483 forms annotated.
We can conduct a mock FDA inspection prior to the FDA audit, providing you with a list of action items that can be addressed and corrected so you are better prepared for the FDA visit.
At MEDIcept, we have both the experience and expertise to help you weather an audit or product safety emergency. We can provide assistance with:
- FDA audit
- Audit response
- Health hazard evaluations
- Medical product recalls
- CAPA plan development, implementation, and effectiveness review
- MDR filings