FDA Inspection
VBM Medizintechnik GmbHVBM Medizintechnik GmbH – FDA Inspection, Jun 10, 2010
Record Details
This FDA Inspection record concerns VBM Medizintechnik GmbH, with an inspection on June 10, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- VBM Medizintechnik GmbH
- Inspection Date
- June 10, 2010
- Product Type
- Devices
View Company Profile
ID · e08b17cb-1f3a-4d7b-b84f-b828441d27d2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 669496
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.120(d)Mixups
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of VBM Medizintechnik GmbH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 24, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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