FDA WARNING_LETTER - Skyline Herbals Private Limited - August 08, 2023

The FDA issued a Warning Letter to Skyline Herbals Private Limited, an OTC drug product manufacturer, including toothpaste, due to a failure to provide requested records. The firm's registered drug ingredients are susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution, which has caused lethal poisoning incidents globally.

On November 15, 2022, the FDA initiated a request for records under section 704(a)(4) of the FD&C Act, which went unanswered. Subsequent attempts via email and phone, including contact with the firm's U.S. Agent, were also unsuccessful. A follow-up written request on December 3, 2022, was confirmed delivered but received no response. Refusing access to records as required by section 704(a) is a prohibited act under section 301(e) of the FD&C Act.

Due to the firm's non-response, the FDA cannot confirm the quality assurance level of drugs manufactured at the facility. Consequently, the FDA may withhold approval of new applications listing Skyline Herbals Private Limited as a drug manufacturer. Shipments from the firm are subject to detention or refusal under section 801(a)(3) of the FD&C Act, and all drugs manufactured by the firm were placed on Import Alert 66-79 on January 5, 2023. The firm