FDA Inspection
Ludwig Medical, IncLudwig Medical, Inc – FDA Inspection, Sep 26, 2017
Record Details
This FDA Inspection record concerns Ludwig Medical, Inc, with an inspection on September 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cbb10957-0a57-43fa-825e-677633a5f37d
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1026753
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Ludwig Medical, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 8, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ludwig Medical, Inc
- FDA Inspection 780305 - 2012-05-07
- FDA Inspection 697474 - 2010-11-08
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