Company
United StatesArrow International LLC, Wyomissing, PA – FDA Inspections
Inspection records and compliance data for Arrow International LLC in Wyomissing, Pennsylvania. 5 FDA inspections on record, last inspected July 14, 2023.
Company Profile
This profile covers Arrow International LLC based in Wyomissing, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected December 18, 2009. Last inspected July 14, 2023.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of procedures, or not maintained1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 14, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1211561 |
| June 20, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 977560 |
| September 24, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 897017 |
| December 18, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 859917 |
| December 18, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 635947 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Arrow International LLC
FEI Number
2518433
Address
35 Innovation Way, Wyomissing, Pennsylvania 19610, United States
Country
United States
ID: 426cb05f-2647-4e98-b984-6a93f9d4b8b9