In Vivo 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 Warns Korean Firm Soleo For GMP Violations, Unapproved Shampoo Drug

Executive Summary

Soleo’s Marum GENtLE THERAPY Shampoo, marketed as an anti-dandruff and hair-growth treatment, is an unapproved new drug, according to FDA. The agency’s warning letter, citing “significant” CGMP violations, follows an August 2018 inspection of the firm’s Pyeongtaek-based facility.

You may also be interested in...

Wild Child Netted Down Under In US FDA Initiative To Inspect All Drug Facilities

FDA says Wild Child, which provides products as a contract manufacturer and for private label sales, violated drug GMPs for products including sun care, lice treatment and acne lotion and attempted to avoid US testing standards by relying on Australian mandates.

Scientific Solutions Global's Formulations Miss OTC Monographs Mark – FDA

Firms' BioTemper, bare and Urea brand products, as formulated and labeled, are unapproved drugs that need approval through NDAs before being sold in US, FDA says in warning. Separate websites firm operates for each brand continues offering sales.

P&G’s NIOXIN Shows How To Address Hair Loss Without An FDA Warning

With FDA scrutinizing the marketplace for cosmetics promoted as drugs, and a clear cautionary statement from the agency about topical products marketed as hair growers or hair-loss preventers, beauty firms have little choice but to incorporate approved OTC drug ingredients in such products. P&G’s professional hair-care brand NIOXIN has done just that with its new Advanced Thinning range featuring minoxidil.





Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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