FDA Inspection
Wexler Surgical, Inc.Wexler Surgical, Inc. – FDA Inspection, Jul 30, 2025
Record Details
This FDA Inspection record concerns Wexler Surgical, Inc., with an inspection on July 30, 2025, issued by the Dallas District Office, covering medical devices & rad health.
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ID · b70a0f52-d8fd-4414-9e88-c437fb4f9b02
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1276955
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Wexler Surgical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 2, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 4, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 20, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Wexler Surgical, Inc.
- FDA Inspection 1187252 - 2022-11-02
- FDA Inspection 958222 - 2016-02-04
- FDA Inspection 918709 - 2015-03-20
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