FDA Inspection 789814 — RH USA INC

RH USA INC — FEI 3001611958

The FDA completed an inspection of RH USA INC on Jul 16, 2012 in Livermore, CA. 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
Jul 16, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Livermore, CA (United States)

Citations

IDCFRDescription
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
342521 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
369621 CFR 820.100(b)Documentation