Mr. Soo Nam Tan
Group Executive Chairman
Fulijaya Manufacturing SDN. BHD.
No. 30, Loring Makmur 13/1
Taman Makmur Industrial Estate
09000 Kulim
Kedah
MalaysiaFEI 1000291174Issued Jan 14, 2026Center for Drug Evaluation and Research (CDER)
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 1000291174.
Violations4
Issue DateJan 14, 2026
Product TypeDrugs
StatusOpen
Letter Details
Firm
Fulijaya Manufacturing SDN. BHD.
Location
Mr. Soo Nam Tan
Group Executive Chairman
Fulijaya Manufacturing SDN. BHD.
No. 30, Loring Makmur 13/1
Taman Makmur Industrial Estate
09000 Kulim
Kedah
Malaysia
FEI Number
1000291174
Country
Malaysia
Issue Date
January 14, 2026
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Fulijaya Manufacturing SDN. BHD., a Malaysian drug manufacturer, was found to be producing adulterated over-the-counter pharmaceuticals due to significant Current Good Manufacturing Practice (CGMP) violations. During a July 2025 inspection, the FDA identified critical failures in laboratory record-keeping, including the absence of complete raw data for microbiological release and stability testing, with the company unable to produce logbooks for tests conducted prior to May 2025. These deficiencies compromised data reliability and prevented the quality unit from verifying compliance with established specifications and standards as required by 21 CFR 211.194(a).
Fulijaya Manufacturing SDN. BHD. FDA Warning Letter, January 14, 2026
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