Dr. Reddy's gets warning letter from USFDA

6 Nov 2015 | By Kartikeya Jain

Dr. Reddy's labs was issued a warning letter by US Food and Drug Administration (USFDA) raising concerns over quality compliance and manufacturing practices followed at its three plants.

The warning was issued following the inspection of its pharmaceutical ingredients manufacturing facilities in Andhra Pradesh and Telangana, as well as oncology formulation manufacturing facility at Visakhapatnam.

The company is required to respond in 15 days.

In context: Dr. Reddy's facing problems again

Introduction What is Dr. Reddy's?

Dr. Reddy's Laboratories is a multinational pharmaceutical company found in 1984 by Anji Reddy.

It is based in Hyderabad, Telangana, India and markets a wide range of pharmaceuticals in India and overseas.

The company has over 190 medications, 60 active pharmaceutical ingredients (APIs) for drug manufacture, diagnostic kits, critical care, and biotechnology products.

It has a net income of $350 million and employs 20,000-people.

A trusted company

In 2014, Dr. Reddy Laboratories was listed among 1200 of India's most trusted brands according to the Brand Trust Report 2014, a study conducted by Trust Research Advisory- a brand analytics company.
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FDA slaps import ban on Reddy's Mexican plant

6 Jul 2011FDA slaps import ban on Reddy's Mexican plant

The USFDA had imposed an import ban on Dr. Reddy's Mexican facility until its manufacturing issues were resolved.

The plant was cited for several manufacturing shortcomes, and the agency had warned the company in June 2011 that it would prohibit its products from the US market.

The company was also a few weeks late in responding to the FDA's warning letter.

27 Jul 2012FDA lifts ban from Reddy's mexican plant

The USFDA had lifted its ban on the import of nearly all drugs from a Mexican plant run by Dr. Reddy's Laboratories.

The FDA said that concerns over potentially adulterated pharmaceuticals from Reddy's plant were resolved.

The company said that FDA had indicated in an inspection report that it was satisfied with all the outstanding action points that Dr. Reddy's had submitted.

21 Aug 2015CPSC accuses Dr. Reddy's of violating packaging rules

The US government's Consumer Product Safety Commission (CPSC) had accused Dr. Reddy's of violating packaging rules for some prescription drugs between 2008 and 2012.

Dr. Reddy's, in its stock exchange filing had said that packaging was intended to prevent children from ingesting harmful substances.

CPSC was planning to file a case against Dr. Reddy's laboratories to seek civil penalties for violating the rules.

6 Nov 2015Dr. Reddy's gets warning letter from USFDA

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6 Nov 2015USFDA warning lead to decline in Dr. Reddy's shares

USFDA had conducted inspections of Dr. Reddy's plants in November 2014, January 2015 and February 2015 and issued a warning on November 6.

Following the warning, the company's share price on BSE declined by Rs.565.60 (13.3%) to Rs.3687 from the previous close of Rs.4252.60.

The company's CEO Prasad said that they would actively engage with the agency to resolve the issues.

9 Dec 2015Dr. Reddy's submits response to warning letter from USFDA

Dr. Reddy's Laboratories submitted its response to the US health regulator on the notice it had received last month.

It said that the "the company is in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants".

The US agency had wanted comprehensive evaluation of "inaccuracies in recorded and reported data".