Company
ChinaAMBU Limited, Xiamen, China – FDA Inspections
Inspection records and compliance data for AMBU Limited in Xiamen. 5 FDA inspections on record, 2 Form 483s, last inspected April 16, 2026.
Company Profile
This profile covers AMBU Limited based in Xiamen, China.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 2, 2011. Last inspected April 16, 2026.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Nonconforming product control1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 16, 2026 | Not classified | Medical Devices & Rad Health | 1314106 |
| October 25, 2018 | Not classified | Medical Devices & Rad Health | 1071591 |
| May 20, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 974130 |
| November 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 857684 |
| June 2, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 733663 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AMBU Limited
FEI Number
3003924186
Address
Xiang Yu F.T. Z., No. C Warehouse & Process Complex Building, Xiamen, China
Country
China
ID: 974ee2ee-6f30-4f31-8290-508efc3c150f