FDA WARNING_LETTER - VE Valley Electronics GmbH - October 18, 2012

This FDA Warning Letter to VE Valley Electronics GmbH, dated January 23, 2013, details violations observed during an October 15-18, 2012, inspection of their Murnau Am Staffelsee, Germany facility, which manufactures Lady Comp, Baby Comp, and Pearly fertility devices.

The devices are deemed misbranded under 21 U.S.C. § 352(t)(2) due to the firm's failure to furnish required material or information under 21 U.S.C. § 360i and 21 CFR Part 803 (Medical Device Reporting - MDR). Specifically, the firm failed to adequately develop, maintain, and implement written MDR procedures (21 CFR 803.17(a)). The revised MDR procedure, P08_06, Index 04, was found inadequate as it omitted key definitions (e.g., "become aware," "caused or contributed") crucial for correct reportability decisions and lacked instructions for obtaining and completing the FDA 3500A form, referencing incorrect forms (FDA 3500, FDA 3417), and omitting the correct submission address.

Additionally, the letter identifies multiple quality system deficiencies under 21 CFR Part 820 (Quality System regulation): 1. **Failure to validate device design (21 CFR 820