FDA Cites Failure to Assess Product Risk in Warning Letter
Comply all the time, not just when FDA announces an inspection.
Tag Archives: Devine Guidance
Endoscopes, Too Little and Too Late
If complex medical devices such as endoscopes and duodenoscopes cannot be reprocessed safely, why is this practice permitted?
Only Two Form 483 Observations Can Equate to a Warning Letter
You must have established procedures for complaint management and MDRs.
Audit Your Own Area, Receive a Warning Letter!
Do not be the organization that fails to perform the audits and attempts to correct the issue after FDA arrives.
The United States of America v. Medtronic., a corporation, and S. Omar Ishrak and Thomas M. Teft, individuals
There is no such thing as minimum or maximum compliance—there is just compliance.
Rework of Nonconforming Product Must Be Documented
As finished devices become more complex and the cost of assembly operations increase significantly, it is imperative that device establishments have the ability to successfully rework nonconforming product.
Chief Jailable Officers Indicted for Adulteration and Misbranding of Medical Devices
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
If the FDA fails to clear or approve a medical device or an expanded indication for use, “No means No!”
You Gotta Validate Design Changes!
Even what may appear as simple design changes need to be reviewed for the need to repeat design validation.
Purchasing Controls is not Rocket Science!
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
A well-balanced purchasing controls program encompasses many tools, but in an effort to meet the requirements delineated within §820.40, the FDA expects establishments to have certain elements in place.
Terms of Endearment
If internal audits are performed with significant rigor and are truly being employed to identify and correct organizational issues, such audits become your best friend.
