Company: Nuclear Cardio Systems Inc.
Product: Emission computed tomography systems
Date: 11/17/04
In addition, our investigators reviewed _____ of your firm’s service reports. _____ of these reports appeared to meet the definition of a complaint [21 CFR 820.3(b)]; however, none of these were considered by you to be complaints and were not included in your complaint file. In a discussion with our investigators, you asserted that “expected failures” and “field problems” did not qualify as complaints. The definition of a complaint, as stated in 21 CFR 820.3(b) is: ” …any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.”
FDA District: Denver District Office
