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FDA Inspection
•Chase Medical•September 13, 2013

FDA Inspection 850281 - Chase Medical - September 13, 2013

Record Details

This FDA Inspection record concerns Chase Medical, with an inspection on September 13, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Chase Medical
Inspection Date
September 13, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · c1edb30f-cba8-4d90-8db8-5c8703273e26

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
850281
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 803.50(a)(2)Individual Report of Malfunction
  2. 21 CFR 820.80(c)Documentation
  3. 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Chase Medical

2
DateClassificationOfficeProject area
September 25, 2024NAICenter for Devices and Radiological HealthCompliance: Devices
July 30, 2010NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Chase Medical
  • FDA Inspection 1250717 - 2024-09-25
  • FDA Inspection 673807 - 2010-07-30

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