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HP Ingredients, Corp. FDA Inspection Record

FEI 3004254638 · Inspections, Form 483s, warning letters and import refusals

HP Ingredients, Corp. is an FDA-inspected facility (FEI 3004254638) located in Bradenton, FL, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 16, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 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
Recalls as the recalling firm
1, latest Sep 26, 2019

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
Apr 16, 2025Voluntary Action Indicated (VAI)Specifications - finished dietary supplement (21 CFR 111.70(e))
Master manufacturing record - record requirements (21 CFR 111.210)
Batch record - required information (21 CFR 111.260)
Oct 15, 2012No Action Indicated (NAI)No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Sep 26, 2019Class IIIF-0069-2020NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads…
Calcium Complex label does not bear a "Contains: milk" advisory in the correct format.

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
HP Ingredients, Corp.
Location
Bradenton, FL (US)
Source
inspections

FDA data resources

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