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FDA Inspection
•Ameriflo2 Incorporated•April 16, 2013

Ameriflo2 Incorporated – FDA Inspection, Apr 16, 2013

Record Details

This FDA Inspection record concerns Ameriflo2 Incorporated, with an inspection on April 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Ameriflo2 Incorporated
Inspection Date
April 16, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 2a6b7ef1-d8b4-40a1-aa31-e865fa9f4803

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
827711
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

2
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Ameriflo2 Incorporated

2
DateClassificationOfficeProject area
March 25, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
May 6, 2011VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Ameriflo2 Incorporated
  • FDA Inspection 980582 - 2016-03-25
  • FDA Inspection 726538 - 2011-05-06

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