• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

FDA issues warning for Claris manufacturing site bought by Baxter

July 18, 2018 By Sarah Faulkner

BaxterThe FDA made public this week a warning letter that it sent to a Claris Injectables pharmaceutical manufacturing site earlier this month.

Baxter (NYSE:BAX) acquired the Ahmedabad, India-based facility in its $625 million purchase of Claris Lifesciences‘ (BOM:533288) injectable drug business. The FDA noted that the site has twice invalidated out-of-specification results without thoroughly investigating the matter.

The U.S. regulatory agency also pointed out that the facility is linked to a “worrisome history” of recalls, including a Class I recall in 2010 of four drugs due in part to non-sterility.

Among other problems noted at the site, the FDA wrote in its letter that investigators observed evidence of water damage inside the facility, including puddles of water and warped ceiling panels.

“It is essential that your plant management maintains the facility in a good state of repair to ensure ongoing suitability for drug manufacturing,” the FDA wrote.

Baxter told Regulatory Focus that it assumed control of the site on July 27, 2017 – hours after the FDA began its inspection – and that the company received the agency’s findings just one week after the Claris buyout closed.

Although Baxter told the news site that it already put corrective actions in place at the manufacturing site, the company added that it is “committed to completing the full integration of the Ahmedabad facility into our quality systems and any other items needed to fully address the Claris warning letter.”

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Baxter International

IN CASE YOU MISSED IT

  • Medtronic to invest $50M in India Diabetes center
  • Flat Medical partners with Mercury Medical on smart syringe distribution
  • Glucotrack to effect a reverse stock split
  • Medtronic unveils ‘MiniMed’ as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS