Company
TaiwanOmnimate Enterprise Co., Ltd., Yilan County, Taiwan – FDA Inspections
Inspection records and compliance data for Omnimate Enterprise Co., Ltd. in Yilan County. 2 FDA inspections on record, 2 Form 483s, last inspected May 08, 2025.
Company Profile
This profile covers Omnimate Enterprise Co., Ltd. based in Yilan County, Taiwan.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected September 12, 2019. Last inspected May 8, 2025.
Most cited issue areas
- Environmental control Lack of or inadequate procedures1 inspection
- Lack of or inadequate process validation1 inspection
- Sampling plans1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 8, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1271152 |
| September 12, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1105896 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Omnimate Enterprise Co., Ltd.
FEI Number
3009771213
Address
Ln. 126, No. 8 Ligong 1st Rd., Sec. 2; Wujie Township, Yilan County, Taiwan
Country
Taiwan
ID: ba17c67f-9164-4177-bd0a-b1b741b44996