Facility

FUSO PHARMACEUTICAL

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010481555
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	2-3-11 Morinomiya Joto-ku Osaka, JP 53685
Registration status	Active · expires 2026
Parent company	3-D Matrix (owner-operator 10092671)

Activity by year

Recalls (1)

Devices registered here (1)

Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Product code PHN (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IITerminated2019-12-02
The boxes used by the shipper were not validated for use during transport.

All facilities operated by 3-D Matrix

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “FUSO PHARMACEUTICAL (FEI 3010481555) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010481555-fuso-pharmaceutical/

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