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.
Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.