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

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 in FDA source data ›

Inspection history

Inspections on file
Nov 21, 2024 · Voluntary Action Indicated (VAI)
Form 483 observations
Nov 21, 2024, 4 observations: Absence of Written Procedures; Procedures not in writing, fully followed; Scientifically sound laboratory controls

FDA record timeline

FDA inspection
VAI classification
Form 483
4 observations
Warning letter
CGMP/Finished Pharmaceuticals/Adulterated

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

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.

Related facilities

Source: FDA public data · status as of 2026-08-22

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