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Halcon Baker, Inc. FDA Inspection Record

FEI 2649635 · Inspections, Form 483s, warning letters and import refusals

Halcon Baker, Inc. is an FDA-inspected facility (FEI 2649635) located in Caguas, PR, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 14, 2025: Voluntary Action Indicated (VAI)
Inspections on record
6 (4 VAI, 2 NAI)
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
Mar 14, 2025Voluntary Action Indicated (VAI)Equipment and utensils - Design and maintenance (21 CFR 117.40)
Hazard analysis - Identification of hazard (21 CFR 117.130(a)(1))
Sanitation preventive controls - Appropriate (Adequate) (21 CFR 117.135(c)(3))
Nov 10, 2021Voluntary Action Indicated (VAI)Pest control (21 CFR 117.35(c))
Hazard Analysis - Identification of Hazard (21 CFR 117.130(a)(1))
Process Controls Monitoring Procedures: Establish Implement (21 CFR 117.145(a))
Dec 16, 2016Voluntary Action Indicated (VAI)Screening (21 CFR 110.20(b)(7))
Effective use of hair restraint (21 CFR 110.10(b)(6))
Floors, walls and ceilings (21 CFR 110.20(b)(4))
Reasonable precautions (21 CFR 110.80)
and 1 more
Mar 13, 2014Voluntary Action Indicated (VAI)No citations listed
May 11, 2011No Action Indicated (NAI)No citations listed
Apr 15, 2009No Action Indicated (NAI)No citations listed

FDA record score

9 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMar 14, 20256 x 16
Inspection classified VAINov 10, 20216 x 0.251.5
Inspection classified VAIDec 16, 20166 x 0.251.5
Inspection classified VAIMar 13, 201410 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
Halcon Baker, Inc.
Location
Caguas, PR (US)
Source
inspections

FDA data resources

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