FDA Inspection 985537 — Forefront Medical Technology (Pte) Ltd.

Forefront Medical Technology (Pte) Ltd. — FEI 3003700453

The FDA completed an inspection of Forefront Medical Technology (Pte) Ltd. on July 27, 2016 in Singapore. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Singapore (Singapore)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures