Daewoo Pharmaceutical, a South Korea-based manufacturer of active pharmaceutical ingredients, has received a warning letter from the FDA. The letter, addressed to Managing Director Jin Soo Baek, stems from an FDA inspection that identified deficiencies in Daewoo’s quality control systems, manufacturing practices, and equipment cleaning validation.
Among the most critical issues cited in the letter are inadequacies in Daewoo’s analytical testing methods and lack of scientific rigor in its stability studies. The FDA noted that Daewoo had failed to employ scientifically sound procedures for verifying the identity, strength, quality, and purity of its APIs. In particular, the company lacked validated methods aligned with US Pharmacopeia standards, casting doubt on the reliability of batch release decisions.
An excerpt from the letter states that Daewoo’s “media fills failed to accurately simulate commercial operations”. The FDA inspection found that aseptic operations simulated at this stage “were not sufficiently representative of aseptic manufacturing operations”.
Inspectors also observed “significantly more interventions performed during routine batch manufacturing that were either not simulated or reduced in quantity in media fills, as compared to what was observed during production. Notably, a substantial number of these interventions during routine production were unplanned.”
Stability testing was also found to be deficient. The agency noted that Daewoo failed to maintain appropriate records and could not demonstrate that its products would remain within specification over time.
Equally concerning was the reliance on visual inspection to verify equipment cleanliness after manufacturing runs. The FDA emphasized that such practices are not acceptable, particularly when equipment is used for multiple APIs, increasing the risk of cross-contamination. Daewoo’s failure to implement robust, quantitative cleaning validation protocols poses a direct threat to product quality and patient safety.
The FDA has requested a comprehensive corrective and preventive action plan and recommended that the company engage a qualified third-party consultant with expertise in cGMP compliance to assist in remediation.
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Teaser image credit: Adobestock.com
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