Company
United StatesWexler Surgical, Inc., Houston, TX – FDA Inspections
Inspection records and compliance data for Wexler Surgical, Inc. in Houston, Texas. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 30, 2025.
Company Profile
This profile covers Wexler Surgical, Inc. based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 2
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 20, 2015. Last inspected July 30, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
- DHR content1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 30, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1276955 |
| November 2, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1187252 |
| February 4, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 958222 |
| March 20, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 918709 |
FDA documents
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Wexler Surgical, Inc.
FEI Number
1000160162
Address
11333 Chimney Rock Rd Ste 110, Houston, Texas 77035, United States
Country
United States
ID: fe4d3dac-4ac8-4a8a-b0b3-017be6a22871