Company
United StatesNipro Renal Soultions USA, Corporation, Lewisberry, PA – FDA Inspections
Inspection records and compliance data for Nipro Renal Soultions USA, Corporation in Lewisberry, Pennsylvania. 4 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected March 27, 2026.
Company Profile
This profile covers Nipro Renal Soultions USA, Corporation based in Lewisberry, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected January 30, 2013. Last inspected March 27, 2026.
Most cited issue areas
- Complaint handling records not maintained1 inspection
- Corrective action not taken1 inspection
- Design and development files not maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 27, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1280338 |
| November 12, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1118873 |
| January 21, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 956271 |
| January 30, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 816183 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
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Company Information
Name
Nipro Renal Soultions USA, Corporation
FEI Number
1000142899
Address
509 Fishing Creek Rd, Lewisberry, Pennsylvania 17339, United States
Country
United States
ID: 0f126a0a-c49a-4f34-93d2-67670e114de1