FDA Warns Indian Manufacturer for Equipment in 'State of Disrepair'
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to an India-based pharmaceutical manufacturer for equipment "in a state of disrepair" and failures in validating a manufacturing process for a drug that was distributed in the US from 2014 to 2016.
The letter, sent 5 July to Vista Pharmaceuticals Limited, notes that FDA received a complaint of metal embedded into one of the tablets the firm manufactured, and FDA investigators said the company "failed to consider whether the poor condition of your equipment may have contributed to the problem."
FDA also noted the company manufactured multiple products for the US market on the equipment found to be in disrepair.
In addition, FDA found in its September 2016 inspection that Vista did not indicate how or when it planned to complete validation of its manufacturing process for isoxsuprine hydrochloride USP, 20 mg tablets, and it has not conducted a retrospective risk assessment to determine the potential effects of its failure to validate that manufacturing process.
Deficiencies found in Vista’s labeling for its isoxsuprine hydrochloride tablets, "including, but not limited to omission of inactive ingredients on the label," render the drug product misbranded, FDA added.
The company did not respond to a request for comment on the warning letter.