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www.fdanews.com/articles/149485-third-party-manufacturing-concerns-draw-complete-response-for-navidea-8217-s-lymphoseek

Third-Party Manufacturing Concerns Draw Complete Response for Navidea’s Lymphoseek

September 14, 2012

The FDA sent Navidea a complete response letter (CRL) on its Lymphoseek injection, citing concerns over quality control at third-party contract manufacturing facilities.

The CRL followed an FDA inspection of those facilities and was not related to any safety or efficacy issues with Lymphoseek (technetium Tc 99m tilmanocept), the company added. It did not provide details about the good manufacturing practice issues raised in the letter.

While Navidea is working with the FDA and its contract manufacturers to put together a response plan, what will happen when FDA inspectors are standing on the threshold to your facility?

Get answers you have and information on other scenarios by attending FDAnews’ Seventh Annual FDA Inspections Summit this coming Wednesday. And don’t let last-minute travel plans deter you from this must-“attend” event. For a discounted price, stream the conference live to your office. CBER, CDRH, ORA … whatever you like in your alphabet soup, the FDA officials you need to listen to will be in attendance.

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