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Eclipse Medcorp, LLC FDA Inspection Record

FEI 3009032449 · Inspections, Form 483s, warning letters and import refusals

Eclipse Medcorp, LLC is an FDA-inspected facility (FEI 3009032449) located in Lewisville, TX, US. RegDataLab tracks 4 FDA inspections and 2 compliance actions at this facility.

What FDA found at this site

Latest inspection
Nov 9, 2018: Voluntary Action Indicated (VAI)
Inspections on record
4 (2 OAI, 2 VAI)
Last OAI inspection
Aug 13, 2015
Warning letters
2 listed by FDA for this FEI, latest Mar 28, 2016

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
Nov 9, 2018Voluntary Action Indicated (VAI)DHR - not or inadequately maintained (21 CFR 820.184)
Software validation for automated processes (21 CFR 820.70(i))
Lack of or inadequate procedures (21 CFR 820.100(a))
Investigation of device failures (21 CFR 820.198(c))
and 2 more
Aug 5, 2016Voluntary Action Indicated (VAI)No citations listed
Aug 13, 2015Official Action Indicated (OAI)No citations listed
Dec 15, 2014Official Action Indicated (OAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Quality Audit/Reaudit - conducted (21 CFR 820.22)
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
and 2 more

FDA record score

2 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

6 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAINov 9, 20186 x 0.251.5
Inspection classified VAIAug 5, 201610 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsMar 28, 201610 years or older, so it adds no points0
Warning letter on FDA's dashboard, which does not show close-outsOct 27, 201510 years or older, so it adds no points0
Inspection classified OAIAug 13, 201510 years or older, so it adds no points0
Inspection classified OAIDec 15, 201410 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Eclipse Medcorp, LLC
Location
Lewisville, TX (US)
Source
inspections

Compliance actions

FDA data resources

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