BAUER UND HASELBARTH-CHIRURG GMBH FDA Inspection Record
BAUER UND HASELBARTH-CHIRURG GMBH is an FDA-registered facility (FEI 3002806450) located in ELLERAU Schleswig-Holstein, DE. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Mar 19, 2026: No Action Indicated (NAI)
- Inspections on record
- 5 (1 OAI, 1 VAI, 3 NAI)
- Last OAI inspection
- Sep 16, 2010
- Warning letters
- 1 listed by FDA for this FEI, latest Dec 22, 2010
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 19, 2026 | No Action Indicated (NAI) | Document Control Procedure Inadequate (ISO 13485:2016 Clause 4.2.4) Purchasing information lacks written agreement regarding notification of changes (ISO 13485:2016 Clause 7.4.2) Process for production and service provision not validated (ISO 13485:2016 Clause 7.5.6) Objectivity and impartiality of internal audit process not ensured (ISO 13485:2016 Clause 8.2.4) and 1 more |
| Dec 15, 2022 | No Action Indicated (NAI) | No citations listed |
| Jul 11, 2018 | No Action Indicated (NAI) | No citations listed |
| Sep 15, 2011 | Voluntary Action Indicated (VAI) | Review and evaluation for investigation (21 CFR 820.198(b)) Equipment control activity documentation (21 CFR 820.72(a)) Lack of procedures, or not maintained (21 CFR 820.40) |
| Sep 16, 2010 | Official Action Indicated (OAI) | Quality audits - auditor independence (21 CFR 820.22) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Nonconforming product control (21 CFR 820.90(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) and 3 more |
FDA record score
0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Sep 15, 2011 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Dec 22, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Sep 16, 2010 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Bauer & Haselbarth - Chirurg GmbH
- Location
- ELLERAU Schleswig-Holstein (DE)
- Source
- device