Company
United StatesFenwal International Inc., San German, PR – FDA Inspections
Inspection records and compliance data for Fenwal International Inc. in San German, Puerto Rico. 4 FDA inspections on record, 1 Form 483, last inspected March 04, 2024.
Company Profile
This profile covers Fenwal International Inc. based in San German, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 17, 2011. Last inspected March 4, 2024.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Equipment Design, Size and Location1 inspection
- Written procedures not established/followed1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 4, 2024 | VAI | Biologics · Blood and Blood Products | 1231736 |
| March 21, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 969766 |
| February 13, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 818407 |
| March 17, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 716648 |
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
Fenwal International Inc.
FEI Number
1000222291
Address
Road 122, Km 0.5 Ave 1, San German, Puerto Rico 00683, United States
Country
United States
ID: 24f2502d-3585-460e-a265-6e3d87a81b9d