David Cosmetic Co., Ltd.

Warning LetterOpen

Mr. Kang Wook Lee CEO David Cosmetic Co., Ltd. 14 Dodam 8-ro Seo-gu Incheon 22667 South KoreaFEI 3015781135Issued May 2, 2022Center for Drug Evaluation and Research | CDER

View Letter

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 3015781135.

Violations2

Issue DateMay 2, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: David Cosmetic Co., Ltd.
Location: Mr. Kang Wook Lee CEO David Cosmetic Co., Ltd. 14 Dodam 8-ro Seo-gu Incheon 22667 South Korea
FEI Number: 3015781135
Country: South Korea
Issue Date: May 02, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

David Cosmetic Co., Ltd. was warned for manufacturing an adulterated antiseptic hand rub product, CALA Advanced Hand Sanitizer Moisturizing with Aloe Vera Extract, that contained benzene contamination at approximately 6 parts per million—unacceptable levels for a known human carcinogen. FDA laboratory testing of a batch in U.S. distribution revealed that the company's quality assurance and Current Good Manufacturing Practice (CGMP) controls were not functioning adequately to prevent this contamination. The company committed to recalling the adulterated batch after FDA's December 2021 teleconference recommending removal of the product from the market.

David Cosmetic Co., Ltd. FDA Warning Letter, May 2, 2022