Company
GermanyBauer & Haselbarth - Chirurg GmbH, Ellerau, Germany – FDA Inspections
Inspection records and compliance data for Bauer & Haselbarth - Chirurg GmbH in Ellerau. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected March 19, 2026.
Company Profile
This profile covers Bauer & Haselbarth - Chirurg GmbH based in Ellerau, Germany.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 16, 2010. Last inspected March 19, 2026.
Most cited issue areas
- DHR content1 inspection
- Document Control Procedure Inadequate1 inspection
- Equipment control activity documentation1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 19, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1312750 |
| December 15, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1198057 |
| July 11, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1062344 |
| September 15, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 753025 |
| September 16, 2010 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 685179 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Bauer & Haselbarth - Chirurg GmbH
FEI Number
3002806450
Address
Sauerbruchstr. 7, Ellerau, Germany
Country
Germany
ID: 60a9e524-7543-43aa-a2f8-6dfc2e6a095a