Drug establishmentActive, Registered FY2026FDA warning letter on file

Natuzen Co.,Ltd.

Natuzen Co.,Ltd. is an FDA-registered drug establishment (FEI 3006731547) located in . The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-11-21) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

May 3, 2024

CGMP/Finished Pharmaceuticals/Adulterated

Find this letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Establishment record

FEI Number

3006731547

Address

289 Namdongdong-ro, ,

Establishment type

Drug establishment

Products / operations

Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Nov 21, 2024 · Voluntary Action Indicated (VAI)

Form 483 observations

Nov 21, 2024, 4 observations: Scientifically sound laboratory controls; Procedures not in writing, fully followed; Absence of Written Procedures

Questions

Is Natuzen Co.,Ltd. registered with the FDA?

Yes. Natuzen Co.,Ltd. is an FDA-registered drug establishment (FEI 3006731547) in . Its current registration status is Active, Registered FY2026.

Has Natuzen Co.,Ltd. received an FDA warning letter?

Yes. FDA issued a warning letter to Natuzen Co.,Ltd.; the most recent is dated May 3, 2024 (CGMP/Finished Pharmaceuticals/Adulterated).

What does Natuzen Co.,Ltd. do?

Natuzen Co.,Ltd.'s FDA-registered operations are: Manufacturing.

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Source: FDA public data · status as of 2026-06-06