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FDA Inspection
•Bauer & Haselbarth - Chirurg GmbH•September 15, 2011

Bauer & Haselbarth - Chirurg GmbH – FDA Inspection, Sep 15, 2011

Record Details

This FDA Inspection record concerns Bauer & Haselbarth - Chirurg GmbH, with an inspection on September 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company
Bauer & Haselbarth - Chirurg GmbH
Inspection Date
September 15, 2011
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 153fc5fc-b06e-41ea-bd7b-2873de8f63ba

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
753025
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

3
  1. 21 CFR 820.40Lack of procedures, or not maintained
  2. 21 CFR 820.72(a)Equipment control activity documentation
  3. 21 CFR 820.198(b)Review and evaluation for investigation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Bauer & Haselbarth - Chirurg GmbH

4
DateClassificationOfficeProject area
March 19, 2026Not classifiedOffice of Inspections and InvestigationsCompliance: Medical Devices
December 15, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
July 11, 2018NAICenter for Devices and Radiological HealthCompliance: Devices
September 16, 2010OAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Bauer & Haselbarth - Chirurg GmbH
  • FDA Inspection 1312750 - 2026-03-19
  • FDA Inspection 1198057 - 2022-12-15
  • FDA Inspection 1062344 - 2018-07-11
  • FDA Inspection 685179 - 2010-09-16

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