FDA WARNING_LETTER - I.E.M. Gmbh - October 20, 2011

During an FDA inspection from October 17-20, 2011, I.E.M. GmbH, a German manufacturer of Class II Blood Pressure Monitors, was found to be in violation of the Federal Food, Drug, and Cosmetic Act. The devices are misbranded under section 502(t)(2) due to failure to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting).

Specifically, the firm failed to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17). Their procedure, "VA22_1," lacked systems for timely event identification, standardized reporting criteria, timely report transmission, and proper documentation of evaluations and submitted reports. A revised procedure provided during the inspection was also deemed inadequate.

Additionally, the firm exhibited nonconformances with the Quality System regulation (21 CFR Part 820), indicating deficiencies in their quality system. Violations include: 1. Failure to establish and maintain adequate corrective and preventive action (CAPA) procedures (21 CFR 820.100(a)), evidenced by not issuing a CAPA for a supplier issue and lacking systemic corrective action for retrospective review of engineering change orders. 2. Failure to adequately document CAPA activities and results (21 CFR 820.100(b)), as the reason for a change