O

ne of India’s largest drug makers has run afoul of US regulators for a plethora of serious violations that include improperly destroying documents, failing to follow procedures for preventing bacterial contamination, and maintaining incomplete lab records.

In a Dec. 23 warning letter, the US Food and Drug Administration cited extensive problems found at a facility run by Wockhardt, which makes numerous medicines for India’s domestic market as well as generics sold in other countries. The missive, which was posted on the agency web site on Tuesday, described problems that were found during an FDA inspection in late 2015.

This is a STAT Plus article and is only available to STAT Plus subscribers.
To read the full story, subscribe to STAT Plus or log in to your account.
Good news: your first 30 days are on us.

Leave a Comment

Please enter your name.
Please enter a comment.

Recommended Stories

Sign up for our biotech newsletter, The Readout

A guide to what’s new in biotech — delivered straight to your inbox every weekday morning.