FDA Inspection
Podo Xingda Medical Co., Ltd.Podo Xingda Medical Co., Ltd. – FDA Inspection, Aug 16, 2012
Record Details
This FDA Inspection record concerns Podo Xingda Medical Co., Ltd., with an inspection on August 16, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 16, 2012
- Product Type
- Devices
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ID · 8c059900-95a5-4bc1-a38c-bb8820ccfb3f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 799748
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.72(b)(1)Calibration standard traceability
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.100(a)(5)Implementing changes
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of Podo Xingda Medical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 1, 2024 | Not classified | Office of Inspections and Investigations | |
| October 31, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 23, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Podo Xingda Medical Co., Ltd.
- FDA Inspection 1231532 - 2024-02-01
- FDA Inspection 1111515 - 2019-10-31
- FDA Inspection 925103 - 2015-04-23
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