FDA Inspection
Shenzhen Pango Electronic Co., LtdShenzhen Pango Electronic Co., Ltd – FDA Inspection, Aug 31, 2017
Record Details
This FDA Inspection record concerns Shenzhen Pango Electronic Co., Ltd, with an inspection on August 31, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- August 31, 2017
- Product Type
- Medical Devices & Rad Health
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ID · b9fa4a6e-f180-409e-b629-26b2af64cac7
Inspection Facts
- Inspection number
- 1026107
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Shenzhen Pango Electronic Co., Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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