Company
ChinaJIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD, Suzhou, China – FDA Inspections
Inspection records and compliance data for JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD in Suzhou. 2 FDA inspections on record, 1 Form 483, last inspected May 29, 2025.
Company Profile
This profile covers JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD based in Suzhou, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 5, 2013. Last inspected May 29, 2025.
Most cited issue areas
- Design validation - documentation1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 29, 2025 | Not classified | Medical Devices & Rad Health | 1272818 |
| September 5, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 851991 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- China NMPA · 1 inspection · last August 15, 2018
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Company Information
Name
JIANGSU RIXIN MEDICAL EQUIPMENT CO., LTD
FEI Number
3007662999
Address
Yangjin Rd, Jinfengzhen Zhangjiagang, Suzhou, China
Country
China
ID: 36bfd0f2-e5bf-4044-bb58-6d8484820f17