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
