FDA Inspection 1258485 — Atmos Medizintechnik Gmbh & Co. KG
The FDA completed an inspection of Atmos Medizintechnik Gmbh & Co. KG on Jan 16, 2025 in Lenzkirch. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 16, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lenzkirch (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |