KM Pharmaceutical Co. Ltd.

Warning LetterOpen

IL MO Kang KM Pharmaceutical Co. Ltd. 121 Pyeongtaekhang-ro 268 beon-gil Poseung-eup Pyeongtaek-si Gyeonggi-do 17953 South KoreaFEI 3010164172Issued Aug 3, 2023Center 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 3010164172.

Violations1

Issue DateAug 3, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: KM Pharmaceutical Co. Ltd.
Location: IL MO Kang KM Pharmaceutical Co. Ltd. 121 Pyeongtaekhang-ro 268 beon-gil Poseung-eup Pyeongtaek-si Gyeonggi-do 17953 South Korea
FEI Number: 3010164172
Country: South Korea
Issue Date: August 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

KM Pharmaceutical Co. Ltd., a manufacturer of over-the-counter drug products including hand sanitizers with ingredients susceptible to diethylene glycol (DEG) and ethylene glycol (EG) contamination, failed to provide access to and copying of records as required by FDA regulations. The company did not respond to multiple record requests sent via email on March 3 and March 16, 2023, followed by a written request on April 17, 2023, despite confirmed delivery. This refusal to permit record access violated section 301(e) of the Federal Food, Drug, and Cosmetic Act. The FDA's enforcement action was prompted by concerns about potential contamination with DEG or EG, substances that have caused lethal poisoning incidents worldwide.

KM Pharmaceutical Co. Ltd. FDA Warning Letter, August 3, 2023