Company
United StatesSVTRONICS INC, Plano, TX – FDA Inspections
Inspection records and compliance data for SVTRONICS INC in Plano, Texas. 4 FDA inspections on record, 2 Form 483s, last inspected February 13, 2026.
Company Profile
This profile covers SVTRONICS INC based in Plano, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected February 16, 2017. Last inspected February 13, 2026.
Most cited issue areas
- Methods for monitoring, measurement, analysis, and improvement not determined1 inspection
- Procedures for validation of processes lack required elements1 inspection
- Records of purchased product verification not maintained1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 13, 2026 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1302724 |
| November 9, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1190677 |
| March 14, 2019 | Not classified | Medical Devices & Rad Health | 1084220 |
| February 16, 2017 | Not classified | Medical Devices & Rad Health | 1005577 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SVTRONICS INC
FEI Number
3005698910
Address
3465 Technology Dr, Plano, Texas 75074, United States
Country
United States
ID: 5c34424a-5770-4d05-8e8e-14ad6700c0f5