1. Home >
  2. Export Import News >
  3. SEZ >
  4. Now, DRL’s Bachupally plant-3 under USFDA radar >
  5. Now, DRL’s Bachupally plant-3 under USFDA radar

Online Export Import Data Search

Recent Searches: No Recent Searches
Complete Training Video : Click Here

Now, DRL’s Bachupally plant-3 under USFDA radar.

Date: 29-04-2017
Subject: Now, DRL’s Bachupally plant-3 under USFDA radar
Hyderabad: In yet another run-in with the US drug watchdog, city-based pharma giant Dr Reddy's Laboratories (DRL)'s plant-3 at Bachupally, Hyderabad, has now been issued with a Form 483 with 11 observations by the United States Food and Drug Administration (USFDA).

"We have been issued a Form-483 with 11 observations. These observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems. We will address them comprehensively within the stipulated time," DRL informed the bourses on Friday.

According to the USFDA, FDA Form 483 is issued to firm at the conclusion of an inspection when investigator has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company's management of objectionable conditions. Recently, USFDA had re-audited DRL's Duvvada unit in Visakhapatnam following which it had issued a Form 483 with 13 observations. Similarly, its API manufacturing unit at Miryalaguda in Telangana was issued a Form 483 with three observations post re-inspection. However, its Srikakulam API SEZ plant was cleared by USFDA with no observations earlier this month.

Source:  The Times Of India

Get Sample Now

Which service(s) are you interested in?
 Export Data
 Import Data
 Exim Help

What is New?

Date: 24-01-2020
Notification No. 01/2020-Customs (ADD)
seeks to amend notification No. 40/2017-Customs(ADD) dated 25-08-2017, to revise anti-dumping duty on imports of "Sodium Nitrite" originating in or exported from China PR, in pursuance of final findings of sunset review investigations issued by DGTR vide notification No. 15/06/2016-DGTR dated the 8th November 2019..

Date: 23-01-2020
A.P. (DIR Series) Circular No.20
Merchanting Trade Transactions (MTT) – Revised Guidelines

Date: 23-01-2020
A.P. (DIR Series) Circular No.19
‘Voluntary Retention Route’ (VRR) for Foreign Portfolio Investors (FPIs) investment in debt – relaxations

Date: 23-01-2020
A.P. (DIR Series) Circular No.18
Investment by Foreign Portfolio Investors (FPI) in Debt

Date: 21-01-2020
Circular No. 4/2020 – Customs
Clarification relating to import of gifts - Reg

Date: 20-01-2020
A.P. (DIR Series) Circular No.17
Introduction of Rupee derivatives at International Financial Services Centres (IFSC)

Date: 17-01-2020
TRADE NOTICE NO. 46/2019-20
Mis-classification goods under 'Others' category at the time of Import- reg.

Date: 16-01-2020
Notification No.05/2020 - Customs (N.T.)
Exchange Rates Notification No.05/2020-Custom (NT) dated 16.01.2020.

Date: 15-01-2020
Notification No. 03/2020- Customs (N.T.)
Notification of Ghasuapara LCS for imports also by amendment of Notification No. 63/1994-Customs dated 21st November 1994

Date: 15-01-2020
Notification No. 04/2020-CUSTOMS (N.T.)
Tariff Notification in respect of Fixation of Tariff Value of Edible Oils, Brass Scrap, Poppy Seed, Areca nut, Gold & Silver - reg.

Exim Guru Copyright © 1999-2020 Exim Guru. All Rights Reserved.
The information presented on the site is believed to be accurate. However, InfodriveIndia takes no legal responsibilities for the validity of the information.
Please read our Terms of Use and Privacy Policy before you use this Export Import Data Directory.


C/o Infodrive India
E-2, 3rd Floor, Kalkaji Main Road
New Delhi - 110019, India
Phone : 011 - 40703001