FDA Inspection
Suntech Medical, Inc.FDA Inspection 1239175 - Suntech Medical, Inc. - May 22, 2024
Record Details
This FDA Inspection record concerns Suntech Medical, Inc., with an inspection on May 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4e0cc734-2c7a-4975-94fd-54e47104c308
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239175
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- Lack of or inadequate complaint procedures
- Nonconforming product, Lack of or inadequate procedures
- Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Suntech Medical, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Suntech Medical, Inc.
- FDA Inspection 946903 - 2015-10-14
- FDA Inspection 778375 - 2012-04-25
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