Company
United StatesUltralite Enterprises Inc, Dacula, GA – FDA Inspections
Inspection records and compliance data for Ultralite Enterprises Inc in Dacula, Georgia. 5 FDA inspections on record, last inspected June 29, 2022.
Company Profile
This profile covers Ultralite Enterprises Inc based in Dacula, Georgia, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected January 29, 2009. Last inspected June 29, 2022.
Most cited issue areas
- Acceptable supplier records, inadequate records1 inspection
- Analysis of data/reports from data sources1 inspection
- Lack of or inadequate organizational structure1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 29, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1175673 |
| May 12, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 971960 |
| November 1, 2012 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 805763 |
| April 18, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 720264 |
| January 29, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 570532 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Ultralite Enterprises Inc
FEI Number
1045025
Address
1870 Fence Rd, Dacula, Georgia 30019, United States
Country
United States
ID: 38d8b2bf-c1f4-4e43-bfdd-6f1ea477254b