In just about any industry, this is a basic part of a quality system.
A twist on the classic holiday song, complete with FDA condemnation.
Inspections are inevitable. If you receive 483s, follow these tips to quickly and adequately respond to the agency.
A company statement aims to set the record straight.
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.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
If your establishment is entering equipment into commerce that is deemed a finished medical device and product servicing is expected during the normal product life-cycle, then compliance with §820.200 is mandated by the QSR. Mandatory means “not optional” in the eyes of the regulatory gods at FDA.
The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.
It’s okay to disagree with a Form 483 observation; however, it is up to the offending organization to draft a salient response that delineates the points of disagreement.