Jang Hyun-pill
Green Pharmaceutical Co. Ltd.
1098 Nongdari-ro
Munbaek-myeon
Jincheon
27863
South Korea
green_qc@greenpharma.co.krFEI 3013338037Issued Aug 23, 2023Center for Drug Evaluation and Research | CDER
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 3013338037.
Violations3
Issue DateAug 23, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Green Pharmaceutical Co. Ltd.
Location
Jang Hyun-pill
Green Pharmaceutical Co. Ltd.
1098 Nongdari-ro
Munbaek-myeon
Jincheon
27863
South Korea
green_qc@greenpharma.co.kr
FEI Number
3013338037
Country
South Korea
Issue Date
August 23, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Green Pharmaceutical Co. Ltd., a South Korean OTC drug manufacturer, was cited for Current Good Manufacturing Practice (CGMP) violations that rendered their drug products adulterated. The company failed to conduct required identity testing on incoming drug components, specifically high-risk shipments that required USP limit testing to ensure they met safety standards for contamination levels. The violations were identified during FDA's review of records submitted in response to a March 2023 information request pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act.
Green Pharmaceutical Co. Ltd. FDA Warning Letter, August 23, 2023
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