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THERATEST LABORATORIES, INC. FDA Inspection Record

FEI 1421346 · Inspections, Form 483s, warning letters and import refusals

THERATEST LABORATORIES, INC. is an FDA-registered facility (FEI 1421346) located in Lombard, IL, US. RegDataLab tracks 5 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 21, 2025: Voluntary Action Indicated (VAI)
Inspections on record
5 (1 VAI, 4 NAI)
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
Recalls as the recalling firm
2, latest Oct 5, 2020

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
Apr 21, 2025Voluntary Action Indicated (VAI)Quality policy and objectives (21 CFR 820.20(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Management review - Lack of or inadequate procedures (21 CFR 820.20(c))
Lack of or inadequate organizational structure (21 CFR 820.20(b))
Jul 21, 2021No Action Indicated (NAI)Documentation (21 CFR 820.80(e))
DHR content (21 CFR 820.184)
DMR - not or inadequately maintained (21 CFR 820.181)
Documented evaluation (21 CFR 820.50(a)(1))
and 1 more
Nov 23, 2016No Action Indicated (NAI)No citations listed
Mar 28, 2013No Action Indicated (NAI)No citations listed
Dec 1, 2009No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Oct 5, 2020Class IIZ-2382-2021EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128
The cross-reactivity of the device may present an increased level of potential false positives. Submitted as EUA202128
Jul 30, 2020Class IIZ-2381-2021EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129
Device did not meet the updated EUA packet requirements for positive percent agreement, thus, not adequately validated. Submitted as…

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Thera Test Laboratories, Inc.
Location
Lombard, IL (US)
Source
device

FDA data resources

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