FDA Inspection 967208 — Ambu Sdn. Bhd.

Ambu Sdn. Bhd. — FEI 3004040397

The FDA completed an inspection of Ambu Sdn. Bhd. on April 15, 2016 in Penang. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 15, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Compliance: Devices
Location
Penang (Malaysia)