FDA Inspection
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.Vincent Medical (Dong Guan) Manufacturing Co., Ltd. – FDA Inspection, May 30, 2013
Record Details
This FDA Inspection record concerns Vincent Medical (Dong Guan) Manufacturing Co., Ltd., with an inspection on May 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 30, 2013
- Product Type
- Devices
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ID · e6e35ce0-e63b-4eac-9ece-714c00fffbb0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 837589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 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 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of Vincent Medical (Dong Guan) Manufacturing Co., Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vincent Medical (Dong Guan) Manufacturing Co., Ltd.
- FDA Inspection 1243499 - 2024-06-21
- FDA Inspection 909101 - 2014-11-06
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