Strides Pharma warned by US regulator over shredded safety documents

18 July 2019
fda_big

India-based drugmaker Strides Pharma (NSE: STAR) has received a warning from the US Food and Drug Administration, after being caught shredding documents related to quality control.

US FDA inspectors said they found records in the process of being destroyed, and that discarded documents were also retrieved from a garbage can.

The letter, which warns of Good Manufacturing Practice (GMP) violations at its Puducherry facility, also alleges the firm made inadequate investigations regarding out-of-specification (OOS) test results.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Today's issue

Company Spotlight





More Features in Generics