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1276955

Wexler Surgical, Inc. — FEI 1000160162

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 30, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Houston, TX (United States)

Facility

Other inspections at this facility

  • 1187252 (VAI Wed Nov 02 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 958222 (VAI Thu Feb 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918709 (OAI Fri Mar 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
310121 CFR 820.30(g)Design validation- Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
369621 CFR 820.100(b)Documentation