The FDA conducts GMP inspections with domestic and foreign manufacturers of medical devices. These inspections may occur at relatively regular intervals or on special occasions (e.g. in product approvals, incidents). Prior to an inspection, the FDA provides notice to foreign companies so they may prepare in advance.
Our services include:
- Preparation for an FDA inspection, ideally with a mock-audit (audit certificate)
- Staff training in what constitutes optimal behavior during the inspection
- Planning and implementation of appropriate corrective actions before the time of inspection
- Support during an FDA inspection
- Advice on answering an incident report (Form 483)
- Best practice for handling a "warning letter"
- Planning and implementing corrective actions
The Capamed Advantage:
- Avoidance of negative fallout from an FDA inspection (e.g. publication of warning letters, an import ban) that can harm your business reputation and bottom line
- The benefit of our consultants’ firsthand knowledge and experience with the FDA inspection process