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•United States

Surgtech Inc, Westlake, OH – FDA Inspections

Inspection records and compliance data for Surgtech Inc in Westlake, Ohio. 1 FDA inspection on record, 1 Form 483, last inspected May 07, 2025.

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Company Profile

This profile covers Surgtech Inc based in Westlake, Ohio, United States.

FDA Inspection History

FDA inspections
1
OAI
0
VAI
0
NAI
1
Form 483s
1
Warning letters
0

Inspected May 7, 2025.

Most cited issue areas

  • Design input - documentation1 inspection
  • Design transfer - Lack of or inadequate procedures1 inspection
  • Design validation- Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
May 7, 2025NAIMedical Devices & Rad Health · Postmarket Assurance: Medical Devices1269576
FDA documents

Form 483s (1)

  • Form 483s · May 7, 2025
People (1)
Laureen M. Geniusz
Person
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Company Information

Name

Surgtech Inc

FEI Number

3011170410

Address

24600 Center Ridge Rd Ste 195, Westlake, Ohio 44145, United States

Country

United States

ID: b399ea7f-1a5d-42d0-886b-f4961a1b1f48

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