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The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.
FDA sent a warning letter, dated April 4, 2019, to Luen Fook Medicine Sdn., Bhd. after an inspection of the company’s Malaysia facility found violations of current good manufacturing practices (CGMP). The inspection, which was conducted from Dec. 10–14, 2018, found similar violations cited in a 2015 inspection.
During the inspection, FDA investigators found that the company had failed to test the identity and strength of active ingredients prior to batch release. The company also lacked written procedures for production and process control. “Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle,” the agency stated in the letter. FDA requested the company provide a validation plan to ensure that control is maintained throughout the product lifecycle.
Cleaning validation was also lacking, according to the warning letter. The agency requested the company provide a comprehensive plan to review its cleaning procedures and validation studies for each piece of equipment; a scientific rationale for its cleaning validation strategy; and a summary of updates to its cleaning validation protocol.
Inadequate quality unit oversight was also mentioned in the letter. The company’s quality unit failed to ensure that appropriate specifications were developed and validation was reviewed and approved. FDA requested the company provide an assessment of its corrective actions and preventative actions to ensure its quality unit performs properly.
The warning letter states that because the violations were previously found in a prior inspection the agency believes “that executive management oversight and control over the manufacture of drugs is inadequate ... Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer.”
FDA placed the firm on Import Alert 66-40 on March 29, 2019.