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

UsernamePublicRestriction
UsernamePublicRestriction

Leiner to redistribute products

This article was originally published in The Tan Sheet

Executive Summary

FDA's Atlanta District Office grants Leiner Healthcare Products permission to begin distributing previously manufactured OTC products if a third-party quality assessment deems the products acceptable under FDA methodology. In an Oct. 22 Securities and Exchange Commission filing, the Carson, Calif.-based firm says it will begin re-distributing a portion of its inventory in December. Leiner suspended its U.S. OTC production and distribution March 20 and initiated a voluntary recall in April after FDA found GMP discrepancies at the firm's Fort Mill, S.C., facility (1"The Tan Sheet" Sept. 24. 2007, p. 12)

You may also be interested in...



Leiner’s Return To U.S. OTC Market Complicated By FDA Warning, DOJ Inquiry

FDA's investigation into manufacturing and quality control issues at Leiner Health Products' South Carolina facility revealed a culture of mismanagement that created a pattern of undetected production errors and overlooked discrepancies regarding product development, according to the agency

J&J To Power Ahead With 10 Launches In Four Years

 Johnson & Johnson has achieved exceptional growth in recent years, and a raft of new products is set to sustain it further. 

Bayer's Efforts To Pioneer Tumor-Agnostic Market In Europe Held Back

Bayer’s drive to lead a new market opportunity in Europe for histology-independent cancer agents like Vitrakvi has been set back by interim decisions from the UK’s NICE and Germany’s IQWiG, but there is a now a clear pathway to follow.

 

Topics

UsernamePublicRestriction

Register

PS101048

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

Cancel