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FDA Inspection
•RH USA INC•July 16, 2012

RH USA INC – FDA Inspection, Jul 16, 2012

Record Details

This FDA Inspection record concerns RH USA INC, with an inspection on July 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
RH USA INC
Inspection Date
July 16, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 05931713-93c2-4956-bdf6-8648fb6583e0

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
789814
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
  3. 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule

Full citation text and observation details available on the Dashboard.

Other FDA inspections of RH USA INC

4
DateClassificationOfficeProject area
April 10, 2024NAICenter for Devices and Radiological HealthCompliance: Devices
October 12, 2017NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
March 27, 2015NAICenter for Devices and Radiological HealthCompliance: Devices
April 30, 2010NAICenter for Devices and Radiological HealthRadiation Control and Health Safety Act
Other documents for RH USA INC
  • FDA Inspection 1236262 - 2024-04-10
  • FDA Inspection 1029403 - 2017-10-12
  • FDA Inspection 920454 - 2015-03-27
  • FDA Inspection 661940 - 2010-04-30

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