FDA Inspection
Hamilton Medical AGHamilton Medical AG – FDA Inspection, Feb 18, 2016
Record Details
This FDA Inspection record concerns Hamilton Medical AG, with an inspection on February 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hamilton Medical AG
- Inspection Date
- February 18, 2016
- Product Type
- Devices
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ID · 4f00eed4-7d17-4109-8165-d93d3bfe20bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 987831
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of Hamilton Medical AG
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 23, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Hamilton Medical AG
- FDA Inspection 1176143 - 2022-07-21
- FDA Inspection 1079095 - 2018-03-23
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