Company
TaiwanSomnics, Inc., Hsinchu County, Taiwan – FDA Inspections
Inspection records and compliance data for Somnics, Inc. in Hsinchu County. 1 FDA inspection on record, 1 Form 483, last inspected June 05, 2025.
Company Profile
This profile covers Somnics, Inc. based in Hsinchu County, Taiwan.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected June 5, 2025.
Most cited issue areas
- Design history file1 inspection
- Lack of or inadequate process validation1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1272457 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Somnics, Inc.
FEI Number
3014674517
Address
Hsinchu Science Park, 5f, Sec. 2, 22 Shengyi Rd.; Zhubei City, Hsinchu County, Taiwan
Country
Taiwan
ID: 82b5f5fb-e1ce-477b-b4b5-9d3bee14b7de