Company
ChinaHangzhou Jinlin Medical Appliances Co., Ltd., Hangzhou, China – FDA Inspections
Inspection records and compliance data for Hangzhou Jinlin Medical Appliances Co., Ltd. in Hangzhou. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected March 19, 2025.
Company Profile
This profile covers Hangzhou Jinlin Medical Appliances Co., Ltd. based in Hangzhou, China.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 0
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 1
First inspected July 26, 2012. Last inspected March 19, 2025.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Design validation - user needs and intended uses1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 19, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1271610 |
| November 1, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1074030 |
| July 26, 2012 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 795124 |
FDA documents
Warning Letters (1)
People (1)
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Company Information
Name
Hangzhou Jinlin Medical Appliances Co., Ltd.
FEI Number
3004056932
Address
Hangzhou E, No. 9 16th Avenue; T Development Zone, Hangzhou, China
Country
China
ID: c16e683c-a35d-4609-81a9-9aeaa2eea02f