BioAsia Worldwide Sdn Bhd

Warning LetterOpen

Mr. Kee Pee Ho Managing Director BioAsia Worldwide Sdn Bhd H-G-01 & H-01-01 Block H – Sekitar 26 Persiaran Hulu Selangor, HICOM Industrial Estate, Seksyen 26 40400 Shah Alam Selangor MalaysiaFEI 3015509166Issued Mar 25, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3015509166.

Violations6

Issue DateMar 25, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: BioAsia Worldwide Sdn Bhd
Location: Mr. Kee Pee Ho Managing Director BioAsia Worldwide Sdn Bhd H-G-01 & H-01-01 Block H – Sekitar 26 Persiaran Hulu Selangor, HICOM Industrial Estate, Seksyen 26 40400 Shah Alam Selangor Malaysia
FEI Number: 3015509166
Country: Malaysia
Issue Date: March 25, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

BioAsia Worldwide Sdn Bhd, a Malaysian drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of over-the-counter pharmaceutical products. The company failed to conduct identity testing on individual drug components and did not validate the reliability of its component suppliers' test analyses at appropriate intervals, instead relying solely on suppliers' certificates of analysis without verification. The FDA determined that the firm's inadequate methods, facilities, and controls rendered its drug products adulterated, and rejected the company's November 2024 response as insufficient due to lack of supporting documentation and inadequate evidence of corrective actions.

BioAsia Worldwide Sdn Bhd FDA Warning Letter, March 25, 2025