Sangleaf Pharm., Co. Ltd.

Warning LetterOpen

Mr. Doo Hyun Yang Sangleaf Pharm., Co. Ltd. DOGOKRO1GIL14 Seoul 06253 South Korea hanil9900@hanmail.netFEI 3012845410Issued Aug 3, 2023Center for Drug Evaluation and Research | CDER

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Violations1

Issue DateAug 3, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Sangleaf Pharm., Co. Ltd.
Location: Mr. Doo Hyun Yang Sangleaf Pharm., Co. Ltd. DOGOKRO1GIL14 Seoul 06253 South Korea hanil9900@hanmail.net
FEI Number: 3012845410
Country: South Korea
Issue Date: August 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Sangleaf Pharm., Co. Ltd., a South Korean manufacturer of OTC drug products including children's toothpaste containing ingredients susceptible to contamination with diethylene glycol (DEG) and ethylene glycol (EG), failed to respond to multiple FDA requests for records and information issued on December 14, 2022, January 11, 2023, and January 27, 2023, in violation of section 704(a)(4) of the FD&C Act. The company did not provide the requested records despite confirmed delivery of communications and follow-up contact attempts by telephone and email. This non-compliance was particularly concerning given that DEG and EG contamination in drug products has caused lethal poisoning incidents worldwide, and the FDA had identified multiple shipments of the company's drug products entering the United States.

Sangleaf Pharm., Co. Ltd. FDA Warning Letter, August 3, 2023