FDA Inspection
Wexler Surgical, Inc.Wexler Surgical, Inc. – FDA Inspection, Feb 4, 2016
Record Details
This FDA Inspection record concerns Wexler Surgical, Inc., with an inspection on February 4, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Wexler Surgical, Inc.
- Inspection Date
- February 4, 2016
- Product Type
- Devices
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ID · ea8151fa-3f36-4032-be47-5ddafb7e616d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958222
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR content
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Other FDA inspections of Wexler Surgical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2025 | NAI | Dallas District Office | Postmarket Assurance: Medical Devices |
| November 2, 2022 | 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 1276955 - 2025-07-30
- FDA Inspection 1187252 - 2022-11-02
- FDA Inspection 918709 - 2015-03-20
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