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IE Gocha Otarashvili — FDA Facility Profile

FEI 3013788691

IE Gocha Otarashvili is an FDA-inspected facility (FEI 3013788691) located in Navazari, GE. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 6, 2019: 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

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
Jun 6, 2019Voluntary Action Indicated (VAI)Still retorts (21 CFR 113.100(a)(1))
Scheduled processes not established (21 CFR 113.83)
Coding - required elements (21 CFR 113.60(c))
Registration (21 CFR 108.35(c)(1))
and 2 more

Facility details

Company
IE Gocha Otarashvili
Location
Navazari (GE)
Source
inspections

FDA data resources

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