Home / Inspections / 1312750

FDA Inspection 1312750 — Bauer & Haselbarth - Chirurg GmbH

Bauer & Haselbarth - Chirurg GmbH — FEI 3002806450

The FDA completed an inspection of Bauer & Haselbarth - Chirurg GmbH on March 19, 2026 in Ellerau. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
March 19, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Ellerau (Germany)

Citations

IDCFRDescription
23039ISO 13485:2016 Clause 4.2.4Document Control Procedure Inadequate
23148ISO 13485:2016 Clause 7.4.2Purchasing information lacks written agreement regarding notification of changes
23167ISO 13485:2016 Clause 7.5.6Process for production and service provision not validated
23224ISO 13485:2016 Clause 8.2.4Objectivity and impartiality of internal audit process not ensured
23238ISO 13485:2016 Clause 8.3.1Nonconforming product not adequately evaluated

Facility

Other inspections at this facility

  • 1198057 (NAI Thu Dec 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1062344 (NAI Wed Jul 11 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753025 (VAI Thu Sep 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 685179 (OAI Thu Sep 16 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources