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MindSight Medical LLC — FDA Facility Profile

FEI 3013913024

MindSight Medical LLC is an FDA-inspected facility (FEI 3013913024) located in Dallas, TX, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 5, 2025: 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
Form 483 and inspection documents
1 in FDA's reading room

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 5, 2025Voluntary Action Indicated (VAI)Actions verified, short and long term solutions (21 CFR 1271.160(b)(3))
Temperature limits (21 CFR 1271.260(e))
Feb 22, 2019Voluntary Action Indicated (VAI)Procedures to meet core CTGP (21 CFR 1271.180(a))
Corrective actions (21 CFR 1271.260(d))

Form 483s and inspection documents

Facility details

Company
MindSight Medical LLC
Location
Dallas, TX (US)
Source
inspections

FDA data resources

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