FDA Inspection
Bauer & Haselbarth - Chirurg GmbHBauer & Haselbarth - Chirurg GmbH – FDA Inspection, Sep 16, 2010
Record Details
This FDA Inspection record concerns Bauer & Haselbarth - Chirurg GmbH, with an inspection on September 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 16, 2010
- Product Type
- Devices
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ID · f9faf43d-3852-4bc6-a737-513aca335318
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 685179
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
7- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Bauer & Haselbarth - Chirurg GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
| December 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 11, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bauer & Haselbarth - Chirurg GmbH
- FDA Inspection 1312750 - 2026-03-19
- FDA Inspection 1198057 - 2022-12-15
- FDA Inspection 1062344 - 2018-07-11
- FDA Inspection 753025 - 2011-09-15
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