FDA Inspection
Atmos Medizintechnik Gmbh & Co. KGAtmos Medizintechnik Gmbh & Co. KG – FDA Inspection, Mar 16, 2017
Record Details
This FDA Inspection record concerns Atmos Medizintechnik Gmbh & Co. KG, with an inspection on March 16, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 16, 2017
- Product Type
- Medical Devices & Rad Health
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ID · 8e2b53a3-906e-40e4-96aa-4eb5a2d580c4
Inspection Facts
- Inspection number
- 1009652
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.70(i)Software validation for automated processes
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Other FDA inspections of Atmos Medizintechnik Gmbh & Co. KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2025 | NAI | Office of Inspections and Investigations | Postmarket Assurance: Medical Devices |
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