FDA Inspection
Ultralite Enterprises IncUltralite Enterprises Inc – FDA Inspection, Apr 18, 2011
Record Details
This FDA Inspection record concerns Ultralite Enterprises Inc, with an inspection on April 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Ultralite Enterprises Inc
- Inspection Date
- April 18, 2011
- Product Type
- Devices
View Company Profile
ID · 7a3b62d2-9291-4f8b-8948-e245de8f922d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 720264
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.20(c)Management review dates
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Other FDA inspections of Ultralite Enterprises Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 12, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 1, 2012 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| January 29, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ultralite Enterprises Inc
- FDA Inspection 1175673 - 2022-06-29
- FDA Inspection 971960 - 2016-05-12
- FDA Inspection 805763 - 2012-11-01
- FDA Inspection 570532 - 2009-01-29
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