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# CGMP Issues at Malaysia’s Fulijaya Manufacturing
- URL: https://www.fdaweb.com/cgmp-issues-at-malaysias-fulijaya-manufacturing/
- Published: 2026-01-27T12:00:00.000Z
- Updated: 2026-09-14T15:31:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160549

A 7/14-7/18/2025 FDA inspection at the Fulijaya Manufacturing drug manufacturing facility in Kulim, Kedah, Malaysia, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/14 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fulijaya-manufacturing-sdn-bhd-719172-01142026?ref=fdaweb.com) says the specific violations were:

- failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
- failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results of stability testing to determine appropriate storage conditions and expiration dates.

FDA says the firm’s quality systems are inadequate and recommends that it engage a qualified consultant to assist it in meeting CGMP requirements. Fulijaya was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.