FDA Inspection
Synthes Tuttlingen GmbHSynthes Tuttlingen GmbH – FDA Inspection, Nov 7, 2013
Record Details
This FDA Inspection record concerns Synthes Tuttlingen GmbH, with an inspection on November 7, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synthes Tuttlingen GmbH
- Inspection Date
- November 7, 2013
- Product Type
- Devices
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ID · d85fb3f7-620c-4c11-8663-ddf7c9f89d71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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Other FDA inspections of Synthes Tuttlingen GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2018 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
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