What Happens After Your FDA Form 483 Response Submission?

November 26th, 2014 by

FDA Warning Letter Form 483 ResponseSo you’ve received an FDA Form 483, but you were prepared. You completed a productive inspection close-out meeting and gained [...] Read More

Life After An FDA Form 483

April 7th, 2014 by

FDA Form 483 Warning LetterFDA inspections don’t always end smoothly. Field agents may decide that the deficiencies they observed were significant enough to issue letters detailing outstanding issues. For firms [...] Read More

Quantifying The Value Of An FDA Mock Audit For Medical Device Manufacturers

March 21st, 2014 by

FDA Mock AuditFDA and ISO inspections are extremely stressful, but they play vital roles in your market viability. Even if you [...] Read More

Using Audits To Improve Your Supplier Quality And Performance

March 19th, 2014 by

Supplier AuditsSupplier oversight and quality is imperative in maintaining the integrity of your product as well as your brand. When done correctly by knowledgeable and experienced consultants, [...] Read More