Lack of Adequate CAPA Procedures Tops FDA’s List of Violations
The agency has issued its list of the most common inspectional observations for FY 2017.
Tag Archives: CAPA
What, No Internal Audits?
Although results don’t need to be shared with FDA during an inspection, an audit still should be performed.
ISO 13485:2016 – What Are the Changes About?
How to prepare for a successful transition.
Ready, Set, Action: Correction, Preventive or Corrective?
Having a grasp on which actions are necessary at various stages of the CAPA process is critical to a quality program.
Your CAPA System: Operate Effectively and Maintain Profitability
A guide to a risk-based CAPA program for device manufacturers.
7 Steps to Respond to FDA 483 Inspection Observations
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
FDA a Pain in the Butt for Hemorrhoid Management System Establishment
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
FDA Says Theranos Device Uncleared, Finds Host of Problems
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.
One, Two, Three Strikes You’re Out…Or, Receive a Warning Letter
It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.
Mistake Proofing
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.
