lnnovision A/S – FDA Warning Letter, Feb 16, 2012

On February 13-16, 2012, an FDA inspection of Innovision A/S in Odense, Denmark, revealed that their Innocor Ergospirometry System, Cardiopulmonary Exercise Testing Option, and LCI Option for Innocor devices are adulterated. The manufacturing, packing, storage, or installation methods do not conform to the Quality System regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30(a)). The Innocor system was not designed using QSR design control requirements. 2. Failure to establish and maintain corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), including analysis of quality data sources. 3. Failure to adequately review and evaluate complaints, and to record reasons for not investigating (21 CFR 820.198(b)), as seen with "Non-Conformance #20283." 4. Failure to adequately maintain complaint files (21 CFR 820.198(a)), with missing approver signatures and closed dates for complaints 20264, 20275, and 20272. 5. Failure to establish and maintain adequate device servicing instructions and procedures (21 CFR 82