Drug establishmentActive, Registered FY2026FDA warning letter on file

BIOASIA WORLDWIDE SDN. BHD.

BIOASIA WORLDWIDE SDN. BHD. is an FDA-registered drug establishment (FEI 3015509166) located in . The facility is active, registered for FY2026. Its most recent FDA inspection on record (2024-10-17) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Mar 25, 2025

CGMP/Finished Pharmaceuticals/Adulterated

Read the 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

3015509166

Address

U-11 Lumut Port Industrial Park Mukim Lumut, ,

Establishment type

Drug establishment

Products / operations

Manufacturing

Registration status

Active, Registered FY2026

Verify this record on FDA.gov ›

Inspection history

Inspections on file

Oct 17, 2024 · Official Action Indicated (OAI)

Form 483 observations

Oct 17, 2024, 11 observations: Training--operations, GMPs, written procedures; Review of representative number of batches; Accelerated stability studies

Questions

Is BIOASIA WORLDWIDE SDN. BHD. registered with the FDA?

Yes. BIOASIA WORLDWIDE SDN. BHD. is an FDA-registered drug establishment (FEI 3015509166) in . Its current registration status is Active, Registered FY2026.

Has BIOASIA WORLDWIDE SDN. BHD. received an FDA warning letter?

Yes. FDA issued a warning letter to BIOASIA WORLDWIDE SDN. BHD.; the most recent is dated Mar 25, 2025 (CGMP/Finished Pharmaceuticals/Adulterated).

What does BIOASIA WORLDWIDE SDN. BHD. do?

BIOASIA WORLDWIDE SDN. BHD.'s FDA-registered operations are: Manufacturing.

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