FDA Inspection
Bauer & Haselbarth - Chirurg GmbHBauer & Haselbarth - Chirurg GmbH – FDA Inspection, Mar 19, 2026
Record Details
This FDA Inspection record concerns Bauer & Haselbarth - Chirurg GmbH, with an inspection on March 19, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 19, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 7ffcc02d-a051-40b3-9ce9-c7cdcced683f
Inspection Facts
- Inspection number
- 1312750
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
- ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
- ISO 13485:2016 Clause 8.2.4Objectivity and impartiality of internal audit process not ensured
- ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated
- ISO 13485:2016 Clause 7.4.2Purchasing information lacks written agreement regarding notification of changes
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Other FDA inspections of Bauer & Haselbarth - Chirurg GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 16, 2010 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bauer & Haselbarth - Chirurg GmbH
- FDA Inspection 1198057 - 2022-12-15
- FDA Inspection 1062344 - 2018-07-11
- FDA Inspection 753025 - 2011-09-15
- FDA Inspection 685179 - 2010-09-16
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