FDA WARNING_LETTER - Invatec S.p.A. - February 07, 2013

An FDA inspection of Medtronic's subsidiary, Invatec S.p.A., in Roncadelle, Italy, from February 4-7, 2013, revealed that the Amphirion Plus PTA Catheter and Driver CE Catheter are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. Failure to verify or validate corrective and preventive actions for effectiveness (21 CFR 820.100(a)(4)), specifically regarding microbial counts exceeding limits in the assembly area. 2. Failure to establish and maintain adequate procedures for validated processes, lacking documentation of test methods (21 CFR 820.75(b)(2)). 3. Failure to establish and maintain adequate procedures for design change validation prior to implementation (21 CFR 820.30(i)). 4. Failure to validate computer software for its intended use according to an established protocol (21 CFR 820.70(i)), with several software-controlled manufacturing equipment for the Amphirion Plus PTA Catheter remaining unvalidated. 5. Failure to establish and maintain adequate calibration procedures with defined accuracy and precision limits (21 CFR 820.72(b)), specifically for (b)(4) calibration.

Additionally,