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HP Ingredients FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

HP Ingredients has 1 FDA recall, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "HP Ingredients" is on file.

What these totals cover: FDA records filed under the name "HP Ingredients".

Latest recall: F-0069-2020 · Class III · Sep 26, 2019
Latest inspection: Apr 16, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	1	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	2	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

HP Ingredients's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	Recall records
2026	0	0
2025	1	0
2024	0	0
2023	0	0
2022	0	0
2021	0	0
2020	0	0
2019	0	1
2018	0	0
2017	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent recalls

1 recall record on Sep 26, 2019.

Number	Class	Product	Date
F-0069-2020	Class III	NIKKENWELLNESS KENZEN brand Calcium Complex Dietary Supplement 60 Tablets. Label reads "Contains…	Sep 26, 2019

Recent FDA inspections

2 inspections from Oct 15, 2012 to Apr 16, 2025.

Date	Site	Product	Classification	FEI
Apr 16, 2025	Bradenton, FL	Food/Cosmetics	Voluntary Action Indicated (VAI)	3004254638
Oct 15, 2012	Bradenton, FL	Food/Cosmetics	No Action Indicated (NAI)	3004254638

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004254638	Bradenton, FL	2	Apr 16, 2025

HP Ingredients and the FDA: common questions

Has HP Ingredients received an FDA warning letter?

No FDA warning letter addressed to the name "HP Ingredients" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has HP Ingredients received an FDA Form 483?

FDA has not published a Form 483 for "HP Ingredients" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect HP Ingredients?

The most recent FDA inspection on file ended Apr 16, 2025 at Bradenton, FL and was classified VAI. FDA has 2 inspections of HP Ingredients on file.

Has HP Ingredients had an FDA recall?

Yes. HP Ingredients has 1 FDA recall on record. The most recent started Sep 26, 2019.

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