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Alps Pharmaceutical Industrial Co., Ltd.

FDA Regulatory Profile

Alps Pharmaceutical Industrial Co., Ltd. has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Alps Pharmaceutical Industrial Co., Ltd." and its spelling variant "Alps Pharmaceutical Industrial Co".

Latest inspection: Oct 17, 2025 · VAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	8	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Alps Pharmaceutical Industrial Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	1	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	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.

Recent FDA inspections

8 inspections from Sep 12, 2011 to Oct 17, 2025.

Date	Site	Product	Classification	FEI
Oct 17, 2025	Hida, Japan	Drugs	Voluntary Action Indicated (VAI)	1073
May 26, 2023	Hida, Japan	Drugs	Voluntary Action Indicated (VAI)	1073
Apr 5, 2019	Hida, Japan	Veterinary	Voluntary Action Indicated (VAI)	1073
Feb 3, 2017	Hida, Japan	Drugs	No Action Indicated (NAI)	1073
Jun 19, 2015	Hida, Japan	Drugs	Voluntary Action Indicated (VAI)	1073
Jan 30, 2014	Hida, Japan	Veterinary	No Action Indicated (NAI)	1073
Sep 13, 2011	Hida, Japan	Veterinary	No Action Indicated (NAI)	1073
Sep 12, 2011	Hida, Japan	Drugs	Voluntary Action Indicated (VAI)	1073

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 1073	Hida, Japan	8	Oct 17, 2025

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