FDA Inspection
Brahms GmbHBrahms GmbH – FDA Inspection, Jul 4, 2013
Record Details
This FDA Inspection record concerns Brahms GmbH, with an inspection on July 4, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Brahms GmbH
- Inspection Date
- July 4, 2013
- Product Type
- Devices
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ID · 3559690b-3805-403c-8642-acf132655ae9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842104
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)General
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.100(b)Procedures
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Other FDA inspections of Brahms GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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