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SEKO MedTec Solutions FDA Inspection Record

FEI 3010032952 · Inspections, Form 483s, warning letters and import refusals

SEKO MedTec Solutions is an FDA-registered facility (FEI 3010032952) located in Oakdale, PA, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 8, 2024: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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
Jul 8, 2024Voluntary Action Indicated (VAI)Lack of or inadequate procedures for labeling (21 CFR 820.120)
Remain legible (21 CFR 820.120(a))
Examination for accuracy (21 CFR 820.120(b))
Lack of or inadequate organizational structure (21 CFR 820.20(b))
Nov 8, 2019Voluntary Action Indicated (VAI)Lack of or inadequate receiving acceptance procedures (21 CFR 820.80(b))

Facility details

Company
SEKO MedTec Solutions
Location
Oakdale, PA (US)
Source
device

FDA data resources

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