Company
ChinaNingbo Luke Medical Devices Co., Ltd., Yuyao City, China – FDA Inspections
Inspection records and compliance data for Ningbo Luke Medical Devices Co., Ltd. in Yuyao City. 1 FDA inspection on record, 1 Form 483, last inspected September 05, 2019.
Company Profile
This profile covers Ningbo Luke Medical Devices Co., Ltd. based in Yuyao City, China.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected September 5, 2019.
Most cited issue areas
- DHR - not or inadequately maintained1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 5, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1101816 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ningbo Luke Medical Devices Co., Ltd.
FEI Number
3013909820
Address
No. 178 Gujiayan, Yangming Road, Yuyao City, China
Country
China
ID: b59cc89a-2e76-444b-8acf-212a95ab6b9a