FDA WARNING_LETTER - Daxal Cosmetics Private Limited - August 08, 2023

The FDA issued Warning Letter 320-23-27 to Daxal Cosmetics Private Limited on August 3, 2023, for failing to provide records requested under section 704(a)(4) of the FD&C Act. Daxal Cosmetics, registered as an OTC drug manufacturer, including toothpaste, uses ingredients susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution.

The FDA sent electronic requests for records on November 15 and November 23, 2022, which went unanswered. A follow-up written request was sent on December 3, 2022, and confirmed delivered, but no response was received. The firm's U.S. Agent also indicated they no longer represent Daxal Cosmetics.

Refusing to permit 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 failure to respond, the FDA has no indication of the quality assurance for drugs manufactured at the facility, especially concerning DEG/EG contamination risks.

Consequently, the FDA may withhold approval of new applications or supplements listing Daxal Cosmetics as a drug manufacturer. Additionally, shipments of drugs from Daxal Cosmetics are subject to detention or refusal of admission under section 801(a)(3) of the FD&C Act, as they