FDA Inspection
Atmos Medizintechnik Gmbh & Co. KGAtmos Medizintechnik Gmbh & Co. KG – FDA Inspection, Jan 16, 2025
Record Details
This FDA Inspection record concerns Atmos Medizintechnik Gmbh & Co. KG, with an inspection on January 16, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- January 16, 2025
- Product Type
- Medical Devices & Rad Health
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ID · ef80b5f9-ffec-4916-ac21-c4bea15cb60b
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1258485
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
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Other FDA inspections of Atmos Medizintechnik Gmbh & Co. KG
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 16, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
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