Regulatory Action Against Ranbaxy
Consent Decree for Toansa, India, Facility
- FDA Press Release1: FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market (1/23/2014)
- FDA Form 483 (PDF - 8.44MB)2 (1/11/2014)
Import Alert and Consent Decree for Mohali, India, Facility
- FDA Press Release3: FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert (9/16/2013)
- FDA Form 483 (PDF – 2MB)4 (9/11/2012)
- FDA Form 483 (PDF – 785KB)5 (12/7/2012)
- DOJ News Release6: Generic Drug Manufacturer Ranbaxy Pleads Guilty and Agrees to Pay $500 Million to Resolve False Claims Allegations, CGMP Violations and False Statements to the FDA (5/13/2013)
Consent Decree for Paonta Sahib, Batamandi, and Dewas, India, Facilities and Ohm Laboratories in Gloversville, N.Y.
- FDA News Release7: Department of Justice files consent decree of permanent injunction against Ranbaxy (1/25/2012)
Application Integrity Policy Action for Paonta Sahib, India, Facility
- FDA AIP Letter to Ranbaxy Laboratories8 (updated 3/2/2009)
- FDA News Release9: FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India (2/25/2009)
Import Alert for Dewas and Paonta Sahib, India, Facilities
- FDA News Release11: FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India (9/16/2008)
- List of Drugs Manufactured at the Dewas and Paonta Sahib Facilities of Ranbaxy Laboratories, Ltd. 12
- Questions and Answers 13
- Warning Letter Dewas, India 14
- Warning Letter Batamandi (Unit II), in Paonta Sahib, India 15
Additional Warning Letters
- Ohm Laboratories, Inc.16 (12/21/2009)
- Paonta Sahib, India17 (6/15/2006)
- Princeton, NJ18 (10/11/2002)
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