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Sun Medical, Inc. — FDA Facility Profile

FEI 1627662

Sun Medical, Inc. is an FDA-inspected facility (FEI 1627662) located in Quinlan, TX, US. RegDataLab tracks 3 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 26, 2020: No Action Indicated (NAI)
Inspections on record
3 (3 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

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
Feb 26, 2020No Action Indicated (NAI)No citations listed
Apr 7, 2016No Action Indicated (NAI)No citations listed
Mar 12, 2012No Action Indicated (NAI)Quality audits - auditor independence (21 CFR 820.22)
Lack of or inadequate process validation (21 CFR 820.75(a))

Facility details

Company
Sun Medical, Inc.
Location
Quinlan, TX (US)
Source
inspections

FDA data resources

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