FDA Inspection 969061 — P.T. Sankei Medical Industries
The FDA completed an inspection of P.T. Sankei Medical Industries on April 14, 2016 in Serang. 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 14, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Serang (Indonesia)