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FDA Inspection
•Ultralite Enterprises Inc•January 29, 2009

Ultralite Enterprises Inc – FDA Inspection, Jan 29, 2009

Record Details

This FDA Inspection record concerns Ultralite Enterprises Inc, with an inspection on January 29, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
Ultralite Enterprises Inc
Inspection Date
January 29, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 7b914b34-0f24-4a66-9528-68105ce00c6d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
570532
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

1
  1. 21 CFR 820.100(a)(1)Analysis of data/reports from data sources

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ultralite Enterprises Inc

4
DateClassificationOfficeProject area
June 29, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
May 12, 2016NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
November 1, 2012NAICenter for Devices and Radiological HealthRadiation Control and Health Safety Act
April 18, 2011VAICenter for Devices and Radiological HealthCompliance: 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 720264 - 2011-04-18

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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