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.
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