Dec

2003

Medron Inc.

Company: Medron Inc.
Product: Various catheters
Date: 12/3/03

We are in receipt of your correspondence dated June 6, 2003 in response to the FD-483 issued at the conclusion of the inspection. Your response is inadequate in that all numbered items listed above were not addressed. However, we acknowledge that you have implemented some corrective action with respect to Quality Audits, Sampling Plans, Rework Procedures, Quality Trending and Software Validation. Your corrective actions will be evaluated and verified during the next inspection of your firm.

FDA District: Denver District Office

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Medron Inc.

Amy Sellers

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