Company
United StatesArrow International, Inc. (subsidiary of Teleflex, Inc.), Chelmsford, MA – FDA Inspections
Inspection records and compliance data for Arrow International, Inc. (subsidiary of Teleflex, Inc.) in Chelmsford, Massachusetts. 7 FDA inspections on record, last inspected June 16, 2021.
Company Profile
This profile covers Arrow International, Inc. (subsidiary of Teleflex, Inc.) based in Chelmsford, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 6
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected January 22, 2010. Last inspected June 16, 2021.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Process changes - review, evaluation and revalidation2 inspections
- Complete files maintained1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 16, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1146471 |
| August 22, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 891557 |
| November 7, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 854476 |
| February 1, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 763683 |
| February 28, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 711599 |
| February 25, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 640302 |
| January 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 636985 |
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, Inc. (subsidiary of Teleflex, Inc.)
FEI Number
3010532612
Address
16 Elizabeth Dr, Chelmsford, Massachusetts 01824, United States
Country
United States
ID: fc931362-71cc-4fdd-9c94-a57f6bab59e4