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Otsuka Pharmaceutical Co Ltd — FDA Facility Profile

FEI 3002807834

Otsuka Pharmaceutical Co Ltd is an FDA-registered facility (FEI 3002807834) located in TOKUSHIMA 771-0132, JP. Registered operations: ANALYSIS; API MANUFACTURE; MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.

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What FDA found at this site

Latest inspection: Mar 22, 2024: Voluntary Action Indicated (VAI)
Inspections on record: 7 (7 VAI)
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
Form 483 and inspection documents: 1 in FDA's reading room
Recalls as the recalling firm: 1, latest Apr 9, 2024
Import refusals: 1

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.

Date	Result	What FDA cited
Mar 22, 2024	Voluntary Action Indicated (VAI)	Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Investigations of discrepancies, failures (21 CFR 211.192) Deviations from laboratory control requirements (21 CFR 211.160(a)) and 1 more
Sep 10, 2019	Voluntary Action Indicated (VAI)	No citations listed
Mar 23, 2018	Voluntary Action Indicated (VAI)	No citations listed
Feb 12, 2016	Voluntary Action Indicated (VAI)	No citations listed
Jun 26, 2014	Voluntary Action Indicated (VAI)	No citations listed
Jul 9, 2012	Voluntary Action Indicated (VAI)	No citations listed
Oct 27, 2011	Voluntary Action Indicated (VAI)	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.

Date	Class	Recall	Product and reason
Apr 9, 2024	Not yet classified	D-0466-2024	Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka… and 3 more products Cross Contamination with Other Products

Form 483s and inspection documents

Mar 22, 2024: 483 on FDA.gov

Facility details

Company: Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Location: TOKUSHIMA 771-0132 (JP)
Registration Expires: Dec 31, 2026
Operations: ANALYSIS; API MANUFACTURE; MANUFACTURE
Source: decrs