FDA Inspection 1241925 — Vela Operations Singapore Pte Ltd

Vela Operations Singapore Pte Ltd — FEI 3009875001

The FDA completed an inspection of Vela Operations Singapore Pte Ltd on Jun 21, 2024 in Singapore. 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). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 21, 2024
Fiscal Year
2024
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Singapore (Singapore)

Citations

IDCFRDescription
366921 CFR 820.20(c)Management review - defined interval, sufficient frequency