Failure to Calibrate Equipment, Seriously?
In just about any industry, this is a basic part of a quality system.
Tag Archives: 483
The Twelve Days of Christmas: Not Exactly!
A twist on the classic holiday song, complete with FDA condemnation.
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.
Amid the Media Firestorm, Theranos Responds to FDA Issues
A company statement aims to set the record straight.
A company statement aims to set the record straight.
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.
FDA Files Consent Decree Against Medtronic and CEO Omar Ishrak
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Medtronic repeatedly fails to correct manufacturing violations related to its Synchromed II Implantable Infusion Pump Systems.
Packaging Modalities Must Be Appropriately Validated
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.
No Established Procedure for Servicing will Result in a Form 483 Observation!
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.
Top 10 Reasons for FDA Warning Letters to Medical Device Firms
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.
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.
So You Received a 483 from FDA, Deal with it!
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.
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.
