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FDA Inspection
•Woven Orthopedic Technologies, LLC•July 23, 2025

Woven Orthopedic Technologies, LLC – FDA Inspection, Jul 23, 2025

Record Details

This FDA Inspection record concerns Woven Orthopedic Technologies, LLC, with an inspection on July 23, 2025, issued by the New England District Office, covering medical devices & rad health.

Company
Woven Orthopedic Technologies, LLC
Inspection Date
July 23, 2025
Product Type
Medical Devices & Rad Health
Office
New England District Office
Person
  • Jeffrey J. Thibodeau (FDA Associated Person)
View Company Profile

ID · 29bab208-6fa9-4240-80d5-d1b95ad6ceac

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1276323
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  2. 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
  3. 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.

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