Company
TaiwanShian Jia Meei Enterprise Co., Ltd., Tainan City, Taiwan – FDA Inspections
Inspection records and compliance data for Shian Jia Meei Enterprise Co., Ltd. in Tainan City. 4 FDA inspections on record (2 OAI), 3 Form 483s, last inspected November 13, 2025.
Company Profile
This profile covers Shian Jia Meei Enterprise Co., Ltd. based in Tainan City, Taiwan.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 2
- VAI
- 1
- NAI
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected June 13, 2012. Last inspected November 13, 2025.
Most cited issue areas
- Design history file1 inspection
- Lack of or inadequate DHR procedures1 inspection
- Lack of or inadequate final acceptance procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 13, 2025 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1294792 |
| September 5, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1251116 |
| August 22, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1102389 |
| June 13, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 791513 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Shian Jia Meei Enterprise Co., Ltd.
FEI Number
3006395305
Address
Pei Hua Village, Kuang Miao District, No 5 Huayuan 2nd St.; Guanmiao Dist., Tainan City, Taiwan
Country
Taiwan
ID: cd564d80-31fc-4a7f-8409-ec0b1b7d41e5