Company
United StatesEagle Endoscopic, Inc., Jacksonville, FL – FDA Inspections
Inspection records and compliance data for Eagle Endoscopic, Inc. in Jacksonville, Florida. 4 FDA inspections on record, 1 Form 483, last inspected April 01, 2022.
Company Profile
This profile covers Eagle Endoscopic, Inc. based in Jacksonville, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 15, 2010. Last inspected April 1, 2022.
Most cited issue areas
- Lack of Written MDR Procedures2 inspections
- Procedures not adequately established or maintained2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 1, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1166292 |
| March 14, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1005018 |
| February 18, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 867333 |
| November 15, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 699000 |
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
Eagle Endoscopic, Inc.
FEI Number
1000220605
Address
388 Brambly Vine Dr, Jacksonville, Florida 32259, United States
Country
United States
ID: 4539aa0b-57a4-4f50-a662-dd905061fe7b