FDA Inspection
CL MedicalCL Medical – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns CL Medical, with an inspection on February 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 92f7858f-f04a-4449-8815-77f22695509c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039256
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of CL Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 5, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CL Medical
- FDA Inspection 801601 - 2012-09-13
- FDA Inspection 627927 - 2009-11-05
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