Company
United StatesGulf Fiberoptics, Inc., Oldsmar, FL – FDA Inspections
Inspection records and compliance data for Gulf Fiberoptics, Inc. in Oldsmar, Florida. 8 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 23, 2023.
Company Profile
This profile covers Gulf Fiberoptics, Inc. based in Oldsmar, Florida, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 4
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected January 12, 2010. Last inspected March 23, 2023.
Most cited issue areas
- Documentation2 inspections
- Lack of or inadequate procedures - Acceptance activities2 inspections
- Design input - documentation1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 23, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1200561 |
| December 18, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1114389 |
| August 13, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 938165 |
| May 6, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 830326 |
| February 3, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 766713 |
| May 3, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 722292 |
| September 17, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 680453 |
| January 12, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 637938 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Gulf Fiberoptics, Inc.
FEI Number
3003768921
Address
448 Commerce Blvd, Oldsmar, Florida 34677, United States
Country
United States
ID: b6615066-b9af-4514-9ef1-203cc562deda