FDA WARNING_LETTER - General Project - January 20, 2011

On January 17-20, 2011, an FDA inspection of General Project s.r.l. in Florence, Italy, identified violations for their MC1 computerized body massager with ultrasonic diathermy, classified as a device. The firm's devices were found to be misbranded under section 502(t)(2) of the Act, due to failure to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

Specifically, the firm failed to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Their response, received February 11, 2011, was deemed inadequate as it lacked documentation of implementation for new procedures (IOI 08.04) and a plan to evaluate previous complaints for reportable events.

Additionally, the firm failed to include agreements in purchasing documents requiring suppliers to notify them of product or service changes, as per 21 CFR 820.50(b). An example cited was the solenoid valve supplier, Sirai, providing a different model (L340V09G instead of L340V04G) without notification, leading to "noisy" valves. The firm's response, indicating future purchase orders would include this requirement and POI 06.01 would be revised, was