FDA Inspection 1034461 — Micro-Mega SA

Micro-Mega SA — FEI 5615

The FDA completed an inspection of Micro-Mega SA on Dec 7, 2017 in Besancon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 7, 2017
Fiscal Year
2018
Product Type
Devices
Project Area
Compliance: Devices
Location
Besancon (France)

Citations

IDCFRDescription
342721 CFR 820.50(a)(2)Supplier oversight
369621 CFR 820.100(b)Documentation
73121 CFR 803.50(a)(1)Report of Death or Serious Injury

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.