Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 Genzyme Details Consent Decree | Contract Pharma

What are you searching for?

Sign in
Breaking News

Genzyme Details Consent Decree

FDA sends Genzyme first draft of consent.

Author Image

By: Tim Wright

Editor-in-Chief, Contract Pharma

During its quarterly earnings announcement, Genzyme provided details of the draft consent decree it received from FDA about the problems at its Allston site. Genzyme will pay $175 million from past profits. Also, if the fill/finish site continues operating after certain deadlines for products, the company will pay 18.5% of the revenues from sales of those products that were processed by the facility. If products are moved from the site but Allston’s problems are not remediated, Genzyme faces fines of $15,000 per day per violation until it is in compliance. The company reported that it is “actively negotiating” with the FDA on those terms.

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics