FDA Inspection 708717 — Amsino Medical (Kunshan) Co., Ltd.

Amsino Medical (Kunshan) Co., Ltd. — FEI 3005669815

The FDA completed an inspection of Amsino Medical (Kunshan) Co., Ltd. on November 4, 2010 in Suzhou. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 4, 2010
Fiscal Year
2011
Product Type
Devices
Project Area
Compliance: Devices
Location
Suzhou (China)

Citations

IDCFRDescription
1471021 CFR 820.150Lack of or inadequate procedures for storage.