Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


FDA warning letter

This article was originally published in The Tan Sheet

Executive Summary

FDA warns Garland, Texas-based GDMI of "significant" current good manufacturing practice violations, including not validating cleaning procedures and failing to conduct identity testing on product from suppliers. Following its June inspection, the company outlined steps to correct violations in a June 30 letter, however, the response lacks "sufficient corrective actions," FDA says in a Nov. 27 warning letter released Jan. 19. FDA cites GDMI for marketing unapproved and misbranded OTC drugs Antiseptic Wound and Skin Cleanser, which contains benzethonium chloride 0.1 percent as the active ingredient. It notes the distributor GDMI manufactures the product for claims on its Web site that the product is effective against certain micro-organisms and diseases they cause, making the product a "drug." Products include Anti-Fungal Cream, Antifungal Treatment and Fire Ant Chigger and Bite

You may also be interested in...

Stada Names New Global Development Head

Stada has named Yann Brun to become the group’s new head of global development, portfolio, regulatory and business development, replacing Robert Knerr. The move is the latest in a string of key appointments at Stada as the firm builds on a series of acquisitions and deals.

Coronavirus Update: Pfizer Urged To Delay Vaccine Submission

A letter from more than 60 leading public health and medical ethics experts has been sent to Pfizer's CEO Albert Bourla.

“The Best Game In Town”: Futura’s Skin-Based CBD Delivery System Shows Great Promise

UK R&D company Futura Medical's new CBD gel shows great potential as an effective cosmetic or even as a new kind of anti-inflammatory medicinal product. 





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts