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ONETIK FDA Inspection Record

FEI 3004265685 · Inspections, Form 483s, warning letters and import refusals

ONETIK is an FDA-inspected facility (FEI 3004265685) located in Macaye, FR. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Feb 17, 2015: No Action Indicated (NAI)
Inspections on record
2 (1 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
Import refusals
10 or more

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 17, 2015No Action Indicated (NAI)No citations listed
Dec 2, 2011Voluntary Action Indicated (VAI)Materials and workmanship (21 CFR 110.40(a))
Drip and condensate (21 CFR 110.20(b)(4))
Running water at suitable temperature (21 CFR 110.37(e))
Manufacturing conditions (21 CFR 110.80(b)(2))
and 1 more

Facility details

Company
ONETIK
Location
Macaye (FR)
Source
inspections

Import refusals

FDA data resources

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