CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
A review of the articles you found most interesting this year.
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation.
CDRH’s Carl Fischer shares the agency’s approach to organizing and managing complaints.
Many companies are unsure of how to complete a complaint investigation when the service and repair process is involved.
A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.
A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.