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BEL STAR S A — FDA Facility Profile

FEI 3003840061

BEL STAR S A is an FDA-registered facility (FEI 3003840061) located in Colombia (COL). Registered operations: MANUFACTURE. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Dec 13, 2019: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 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
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
Dec 13, 2019Voluntary Action Indicated (VAI)Training , Education , Experience overall (21 CFR 211.25(a))
Calibration/Inspection/Checking not done (21 CFR 211.68(a))
Washing and toilet facilities are deficient (21 CFR 211.52)
Scientifically sound laboratory controls (21 CFR 211.160(b))
Feb 12, 2016Voluntary Action Indicated (VAI)No citations listed

Facility details

Company
Bel Star S.A.
Location
Colombia (COL)
Registration Expires
Dec 31, 2026
Operations
MANUFACTURE
Source
decrs

Import refusals

FDA data resources

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