So you've received an FDA Form 483, but you were prepared. You completed a. [...] Read More
What Happens After Your FDA Form 483 Response Submission?
November 26th, 2014 by Henry MacartneyPosted in Quality Management Systems
Life After An FDA Form 483
April 7th, 2014 by Zuhdi HusseinFDA inspections don't always end smoothly. Field agents may decide that the. [...] Read More
Posted in Notice of Inspectional Observations
Quantifying The Value Of An FDA Mock Audit For Medical Device Manufacturers
March 21st, 2014 by James FrancumFDA and ISO inspections are extremely stressful, but they play vital roles in. [...] Read More
Posted in Quality System/GMP Regulation
Using Audits To Improve Your Supplier Quality And Performance
March 19th, 2014 by James FrancumSupplier oversight and quality is imperative in maintaining the integrity of. [...] Read More
Posted in Medical Device Supplier Audits
