An explanation of these principles and the actions that must be addressed in compliance with 21 CFR 820, ISO 13485 and the EU MDR.
The agency has issued its list of the most common inspectional observations for FY 2017.
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.
How to prepare for a successful transition.
Having a grasp on which actions are necessary at various stages of the CAPA process is critical to a quality program.
A guide to a risk-based CAPA program for device manufacturers.
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
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.
It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.