FDA WARNING_LETTER - o.m.t. Oberflachen - und Materialtechnologie Gmbh - April 24, 2014

On August 5, 2014, the FDA issued a Warning Letter to o.m.t. Oberflachen- und Materialtechnologie GmbH, a German manufacturer of orthopedic devices (bone screws) and manual instruments, following an inspection from April 22-24, 2014. The inspection revealed the firm's devices are 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).

Specifically, the firm failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures as required by 21 CFR 803.17. The firm's May 8, 2014 response, stating an adverse event procedure exists but was not provided, was deemed inadequate.

Additionally, the inspection identified several quality system deficiencies under 21 CFR Part 820 (Quality System regulation): 1. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)), specifically regarding prompt review and investigation of reportable events. The firm's response was inadequate as procedures were not provided. 2. Failure to document monitoring and control methods/data for validated processes (21 CFR 820.75(b)(2)). The firm could not provide a validation report