FDA Inspection
Shian Jia Meei Enterprise Co., Ltd.Shian Jia Meei Enterprise Co., Ltd. – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns Shian Jia Meei Enterprise Co., Ltd., with an inspection on August 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9b149470-3deb-4a27-be7b-7ee323ed7c95
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1102389
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Shian Jia Meei Enterprise Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 13, 2025 | OAI | Compliance: Devices | |
| September 5, 2024 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 13, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Shian Jia Meei Enterprise Co., Ltd.
- FDA Inspection 1294792 - 2025-11-13
- FDA Inspection 1251116 - 2024-09-05
- FDA Inspection 791513 - 2012-06-13
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