Antonio Mineiro E Andrade, Lda — FDA Facility Profile

FEI 3011282461

Antonio Mineiro E Andrade, Lda is an FDA-inspected facility (FEI 3011282461) located in Ribeira Grande, PT. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.

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What FDA found at this site

Latest inspection
Jul 28, 2022: No Action Indicated (NAI)
Inspections on record
3 (1 OAI, 1 VAI, 1 NAI)
Last OAI inspection
Feb 12, 2016
Warning letters
1 listed by FDA for this FEI, latest Jun 28, 2016
Import refusals
2

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
Jul 28, 2022No Action Indicated (NAI)No citations listed
Jul 11, 2018Voluntary Action Indicated (VAI)Personnel (21 CFR 117.10)
Sanitary operations - Plant maintenance (21 CFR 117.35(a))
Pest control (21 CFR 117.35(c))
Manufacturing, processing, packing, holding - Controls (21 CFR 117.80(c))
and 2 more
Feb 12, 2016Official Action Indicated (OAI)As source of contamination (21 CFR 110.37(b)(3))
Monitoring - adequacy (21 CFR 123.6(c)(4))
Critical control points (21 CFR 123.6(c)(2))

Facility details

Company
Antonio Mineiro E Andrade, Lda
Location
Ribeira Grande (PT)
Source
inspections

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