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CRYO-DYNAMICS INC. — FDA Facility Profile

FEI 3030478415

CRYO-DYNAMICS INC. is an FDA-registered facility (FEI 3030478415) located in Southlake, TX, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Dec 4, 2025: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 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
Dec 4, 2025Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Documentation of software validation (21 CFR 820.70(i))
Quality Audit/Reaudit - conducted (21 CFR 820.22)
and 1 more

Form 483s and inspection documents

Facility details

Company
Cryo-Dynamics, Inc.
Location
Southlake, TX (US)
Source
device

FDA data resources

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