FDA Inspection
LMT MEDICAL SYSTEMS GMBHLMT MEDICAL SYSTEMS GMBH – FDA Inspection, Jan 19, 2017
Record Details
This FDA Inspection record concerns LMT MEDICAL SYSTEMS GMBH, with an inspection on January 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a02bef28-fbec-4504-99f1-a880d453eb91
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1000150
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management 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 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of LMT MEDICAL SYSTEMS GMBH
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LMT MEDICAL SYSTEMS GMBH
- FDA Inspection 1234658 - 2024-02-15
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