FDA Inspection 890836 — Dongguan Sure On Plastic & Fiber Products Co., LTD.

Dongguan Sure On Plastic & Fiber Products Co., LTD. — FEI 3003191210

The FDA completed an inspection of Dongguan Sure On Plastic & Fiber Products Co., LTD. on July 24, 2014 in Dongguan. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 24, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Dongguan (China)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
330921 CFR 820.120(b)Examination for accuracy
331321 CFR 820.120(d)Records, DHR {see also 820.184(e)}
369621 CFR 820.100(b)Documentation
50221 CFR 820.60Identification procedures, Lack of or inadequate procedures