FDA Inspection 747263 — Infus Medical (Thailand) Co., Ltd.

Infus Medical (Thailand) Co., Ltd. — FEI 1000434163

The FDA completed an inspection of Infus Medical (Thailand) Co., Ltd. on August 25, 2011 in Preaksa. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 25, 2011
Fiscal Year
2011
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Preaksa (Thailand)

Citations

IDCFRDescription
315921 CFR 820.184DHR content
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures