Daxal Cosmetics Private Limited

Warning LetterOpen

Daxal Desai Daxal Cosmetics Private Limited 347, Mahagujarat Industrial Estate Sarkhej Bawla Road, N.H. 8A Moraiya, Sanand, Ahmedabad 382213 Gujarat India daxal.p.desai@gmail.comFEI 3006127560Issued 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 3006127560.

Violations1

Issue DateAug 3, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Daxal Cosmetics Private Limited
Location: Daxal Desai Daxal Cosmetics Private Limited 347, Mahagujarat Industrial Estate Sarkhej Bawla Road, N.H. 8A Moraiya, Sanand, Ahmedabad 382213 Gujarat India daxal.p.desai@gmail.com
FEI Number: 3006127560
Country: India
Issue Date: August 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Daxal Cosmetics Private Limited, an Indian manufacturer of over-the-counter drug products including toothpaste containing ingredients susceptible to contamination with diethylene glycol (DEG) and ethylene glycol (EG), failed to comply with FDA record access requests issued on November 15, 2022, November 23, 2022, and December 3, 2022 pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act. Despite confirmed delivery of the written requests and follow-up communications, the company refused to provide access to or copying of the requested records, which constitutes a prohibited act under section 301(e) of the FD&C Act. The FDA's enforcement action was prompted by multiple shipments of the company's drug products into the United States and concerns about DEG and EG contamination, which have historically caused lethal poisoning incidents worldwide.

Daxal Cosmetics Private Limited FDA Warning Letter, August 3, 2023