FDA Warning Letter — P.T. Sankei Medical Industries
The FDA took a Warning Letter action against P.T. Sankei Medical Industries on September 19, 2023 (Serang, Indonesia). The action was issued by CDRH and concerns devices products. This facility has 2 recent FDA inspections on record.
Action Details
- Facility
- P.T. Sankei Medical Industries
- Date
- September 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Center
- CDRH
- Location
- Serang (Indonesia)