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FDA Inspection
•Best Nomos•May 8, 2025

Best Nomos – FDA Inspection, May 8, 2025

Record Details

This FDA Inspection record concerns Best Nomos, with an inspection on May 8, 2025, issued by the Philadelphia District Office, covering medical devices & rad health.

Company
Best Nomos
Inspection Date
May 8, 2025
Product Type
Medical Devices & Rad Health
Office
Philadelphia District Office
People
  • Dennis R. Hock (Company Rep)
  • Kara J. Wright
View Company Profile

ID · 58c3f9db-1ec9-4373-bd65-375aa24f1947

Inspection Facts

Inspection number
1269780
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.198(c)Investigation of device failures
  3. 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Best Nomos

5
DateClassificationOfficeProject area
July 11, 2018NAICenter for Devices and Radiological HealthCompliance: Devices
February 3, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
October 5, 2012VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
October 21, 2010VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
January 29, 2009NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Best Nomos
  • FDA Inspection 1060876 - 2018-07-11
  • FDA Inspection 960336 - 2016-02-03
  • FDA Inspection 802846 - 2012-10-05
  • FDA Inspection 695287 - 2010-10-21
  • FDA Inspection 560514 - 2009-01-29

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