Sabila, SRL — FDA Facility Profile

FEI 3011281612

Sabila, SRL is an FDA-inspected facility (FEI 3011281612) located in Villa Gonzalez. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Sep 29, 2017: Voluntary Action Indicated (VAI)
Inspections on record
3 (2 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
1 listed by FDA for this FEI, latest Jul 1, 2013

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
Sep 29, 2017Voluntary Action Indicated (VAI)Materials and workmanship (21 CFR 110.40(a))
Screening (21 CFR 110.20(b)(7))
Personnel (21 CFR 114.10)
Scheduled process (21 CFR 114.80(a)(1))
and 1 more
Jun 15, 2016Voluntary Action Indicated (VAI)Precautions against contamination--micro, foreign substances (21 CFR 110.10(b)(9))
Q.C. instrument accuracy, maintenance (21 CFR 110.40(f))
Screening (21 CFR 110.20(b)(7))
Effective use of hair restraint (21 CFR 110.10(b)(6))
and 3 more
Dec 20, 2012No Action Indicated (NAI)Storage of personal items (21 CFR 110.10(b)(7))
Personal food/drink/tobacco (21 CFR 110.10(b)(8))
Materials and workmanship (21 CFR 110.40(a))
Q.C. instrument accuracy, maintenance (21 CFR 110.40(f))
and 18 more

Facility details

Company
Sabila, SRL
Location
Villa Gonzalez
Source
inspections

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