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Preventics Inc. FDA Inspection Record

FEI 2050048 · Inspections, Form 483s, warning letters and import refusals

Preventics Inc. is an FDA-inspected facility (FEI 2050048) located in Scottsdale, AZ, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 18, 2025: Voluntary Action Indicated (VAI)
Inspections on record
4 (3 VAI, 1 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
1, latest Apr 30, 2025

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 18, 2025Voluntary Action Indicated (VAI)Manufacturing operations - sanitation (21 CFR 111.360)
Specifications - labels, packaging (21 CFR 111.70(d))
Quality control - representative samples (21 CFR 111.105(f))
Written procedures - follow; holding and distribution (21 CFR 111.453)
and 10 more
Dec 9, 2021Voluntary Action Indicated (VAI)No citations listed
Oct 17, 2016Voluntary Action Indicated (VAI)No citations listed
May 30, 2012No 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
Apr 30, 2025Class IIIH-0091-2025Prothin, dietary supplement. Seven Packets containing 2 tablets and 4 capsules. Legere… and 5 more products
Undeclared Allura Red (Red No. 40) and Brillant Blue (Blue No.1) used in gelatin capsules.

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
Preventics Inc.
Location
Scottsdale, AZ (US)
Source
inspections

FDA data resources

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