HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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 To Toughen OTC Oversight, Seek New Authority In Wake Of J&J Recalls

This article was originally published in The Tan Sheet

Executive Summary

FDA will monitor more closely OTC manufacturing operations and require comprehensive changes at firms with systemic quality deficiencies as a result of its investigation of Johnson & Johnson's McNeil Consumer Healthcare

You may also be interested in...

J&J Woes, Pharma Switch Outlook Lead "The Tan Sheet" 2010 Topics

Quality control problems for Johnson & Johnson's McNeil Consumer Healthcare business and the regulatory and congressional scrutiny that followed dominated the attention of drug and dietary supplement industry stakeholders in 2010.

J&J Delivers No Evidence FDA Knew Of "Phantom" Recall - Congressional Staff

Johnson & Johnson failed to provide proof that FDA acknowledged the firm's plan for a "phantom" recall of a Motrin product, according to Capitol Hill staff

FDA Warns In Recall Guidance Agency Has Arsenal Of Enforcement Options

FDA warns that even though it cannot mandate a drug recall, "it can take more authoritative legal actions" against firms selling defective health products

Related Content


Latest News



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