FDA Inspection
Medicatech UsaMedicatech Usa – FDA Inspection, Oct 22, 2024
Record Details
This FDA Inspection record concerns Medicatech Usa, with an inspection on October 22, 2024, issued by the Los Angeles District Office, covering medical devices & rad health.
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ID · 7b999503-3dc2-43a5-b629-2601b0bdb3d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1252312
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of Medicatech Usa
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medicatech Usa
- FDA Inspection 702863 - 2010-12-19
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