Moneycontrol
Last Updated : Nov 09, 2018 01:46 PM IST | Source: Moneycontrol.com

Dr Reddy's Laboratories slips 2% on report of US FDA handing out observations to Duvvada unit

The said observations include no written procedures for production and process controls. The company's quality unit failed to implement adequate and reliable controls.

Moneycontrol News @moneycontrolcom
 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

Shares of Dr Reddy’s Laboratories slipped 2 percent intraday as investors reacted to the news of USFDA issuing observations to the company's Duvvada unit.

The US health regulator USFDA (United States Food and Drug Administration) issued observations after inspecting its Duvvada facility in the month of October, CNBC-TV18 reported.

The said observations include no written procedures for production and process controls. The company's quality unit failed to implement adequate and reliable controls.

Also, manufacturing defects not considered for batch disposition of previous products. The company not followed procedures to prevent microbiological contamination.

The aseptic processing areas deficient to monitor environmental conditions and failure to review any unexplained discrepancy w.r.t distribution.

Company's employees engaged in manufacturing and processing lack training and experience, batch production & control records deficient and field alert report not submitted in three working days, are the other major observations.

At 13:25 hrs Dr Reddy’s Laboratories was quoting at Rs 2,402, down Rs 48.95, or 2 percent on the BSE.
First Published on Nov 9, 2018 01:46 pm
Loading...
Sections
Follow us on
Available On