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FDA Inspection
•Brahms GmbH•October 28, 2010

Brahms GmbH – FDA Inspection, Oct 28, 2010

Record Details

This FDA Inspection record concerns Brahms GmbH, with an inspection on October 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company
Brahms GmbH
Inspection Date
October 28, 2010
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · bc458d84-52ee-4061-8015-8e03b588f8f2

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
699202
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.40(a)Document review, approval by designated individual
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.198(a)Lack of or inadequate complaint procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Brahms GmbH

1
DateClassificationOfficeProject area
July 4, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Brahms GmbH
  • FDA Inspection 842104 - 2013-07-04

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