Apicola De Allende, S.A. De C.V. — FDA Facility Profile

FEI 3008831556

Apicola De Allende, S.A. De C.V. is an FDA-inspected facility (FEI 3008831556) located in Allende, MX. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jan 13, 2022: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 OAI, 1 VAI)
Last OAI inspection
Aug 19, 2016
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
8

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
Jan 13, 2022Voluntary Action Indicated (VAI)Hazard Analysis - Identification of Hazard (21 CFR 117.130(a)(1))
Preventive Controls - Identify (21 CFR 117.135(a)(1))
Aug 19, 2016Official Action Indicated (OAI)Procedures - equipment - cleaning, sanitizing (21 CFR 111.25(c))
Batch record - component; unique identifier (21 CFR 111.260(d))
Batch record - initials; each step (21 CFR 111.260(j)(2))
Specifications - identity, purity, strength, composition (21 CFR 111.70(e))
and 3 more

Facility details

Company
Apicola De Allende, S.A. De C.V.
Location
Allende (MX)
Source
inspections

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