FDA finds rusty equipment at Vista Pharma drug plant

The U.S. Food and Drug Administration on July 5 issued a warning letter to Vista Pharmaceuticals, citing "significant violations of current good manufacturing practice regulations for finished pharmaceuticals."

While touring Vista Pharmaceuticals' manufacturing facility in India in September 2016, the FDA observed corrosion and holes on three pieces of equipment used to make drugs for the treatment of vascular disease. The regulatory agency also identified misbranding issues and found the company had not validated its production processes for the drugs.

The company responded to the FDA's findings in October 2016, detailing actions taken to address the issues previously identified by the FDA. In the July letter, the FDA said Vista failed to properly address the manufacturing issues.

If Vista does not adequately correct the identified violations, the FDA may not grant approval to future Vista applications to market drugs.

To read the FDA's letter in full, click here.

More articles on the supply chain: 
FDA approves 1st sickle cell treatment in two decades 
Sanofi acquires US vaccines biotech for $650M: 3 things to know 
How Trump's efforts to lower drug prices affect the industry — 4 questions on a possible executive order

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars