Company
GermanyAtmos Medizintechnik Gmbh & Co. KG, Lenzkirch, Germany – FDA Inspections
Inspection records and compliance data for Atmos Medizintechnik Gmbh & Co. KG in Lenzkirch. 2 FDA inspections on record, 2 Form 483s, last inspected January 16, 2025.
Company Profile
This profile covers Atmos Medizintechnik Gmbh & Co. KG based in Lenzkirch, Germany.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected March 16, 2017. Last inspected January 16, 2025.
Most cited issue areas
- DHR documentation of label release {see also 820.184}1 inspection
- Documentation1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1258485 |
| March 16, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1009652 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Atmos Medizintechnik Gmbh & Co. KG
FEI Number
3003169291
Address
Ludwig-Kegel-Str. 16, Lenzkirch, Germany
Country
Germany
ID: 25474050-d561-44d0-a912-5f261343d2b6