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FDA Inspection
•RTF Manufacturing. Co. LLC•April 14, 2015

RTF Manufacturing. Co. LLC – FDA Inspection, Apr 14, 2015

Record Details

This FDA Inspection record concerns RTF Manufacturing. Co. LLC, with an inspection on April 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
RTF Manufacturing. Co. LLC
Inspection Date
April 14, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 54d0367b-a8c9-4fb6-b393-e5ee49c1cd58

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
922273
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
  3. 21 CFR 820.20(e)Quality System Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of RTF Manufacturing. Co. LLC

1
DateClassificationOfficeProject area
March 27, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for RTF Manufacturing. Co. LLC
  • FDA Inspection 774733 - 2012-03-27

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