Skyline Herbals Private Limited

Warning LetterOpen

Vikram Vakil Skyline Herbals Private Limited 10, Mahagujarat Industrial Estate Opposite Zydus Cadila Research Center Moraiya, Ahmedabad 382213 Gujarat India skylineherbal009@gmail.comFEI 3017104669Issued 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 3017104669.

Violations1

Issue DateAug 3, 2023

Product TypeOther

StatusOpen

Letter Details

Firm: Skyline Herbals Private Limited
Location: Vikram Vakil Skyline Herbals Private Limited 10, Mahagujarat Industrial Estate Opposite Zydus Cadila Research Center Moraiya, Ahmedabad 382213 Gujarat India skylineherbal009@gmail.com
FEI Number: 3017104669
Country: India
Issue Date: August 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Other
Status: Open

Summary

Skyline Herbals Private Limited, an OTC drug manufacturer registered to produce toothpaste and other products containing ingredients susceptible to contamination with diethylene glycol (DEG) and ethylene glycol (EG), failed to respond to three separate FDA requests for records issued between November 2022 and December 2022 pursuant to section 704(a)(4) of the FD&C Act. The company did not provide the requested records or information despite confirmed delivery of written communications and a direct telephone conversation with its registered U.S. Agent. This refusal to permit access to and copying of required records constituted a prohibited act under section 301(e) of the FD&C Act, with particular concern given that DEG and EG contamination has caused lethal poisoning incidents in humans globally.

Skyline Herbals Private Limited FDA Warning Letter, August 3, 2023