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SURGTECH, INC. — FDA Facility Profile

FEI 3011170410

SURGTECH, INC. is an FDA-registered facility (FEI 3011170410) located in Westlake, OH, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
May 7, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 7, 2025Voluntary Action Indicated (VAI)Design input - documentation (21 CFR 820.30(c))
Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
Supplier oversight (21 CFR 820.50(a)(2))

Facility details

Company
Surgtech Inc
Location
Westlake, OH (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.