Regulatory Action Against Ranbaxy
These facilities are now owned by Sun Pharmaceutical.
Consent Decree for Toansa, India, Facility
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FDA Press Release: FDA prohibits Ranbaxy’s Toansa, India facility from producing and distributing drugs for the U.S. market (1/23/2014)
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FDA Form 483 (PDF - 8.44MB) (1/11/2014)
Import Alert and Consent Decree for Mohali, India, Facility
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FDA Press Release: FDA prohibits manufacture of FDA-regulated drugs from Ranbaxy’s Mohali, India, plant and issues import alert (9/16/2013)
- FDA Form 483 (PDF – 785KB) (11/29/2016)
- FDA Form 483 (PDF – 785KB) (12/7/2012)
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FDA Form 483 (PDF – 2MB) (9/11/2012)
Department of Justice Action Against Ranbaxy
- DOJ News Release: 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.
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FDA News Release: 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 Laboratories (updated 3/2/2009)
- FDA News Release: FDA Takes New Regulatory Action Against Ranbaxy’s Paonta Sahib Plant in India (2/25/2009)
- Application Integrity Policy List
Import Alert for Dewas and Paonta Sahib, India, Facilities
- FDA News Release: 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.
- Questions and Answers
- Warning Letter Dewas, India
- Warning Letter Batamandi (Unit II), in Paonta Sahib, India
Additional Warning Letters
- Ohm Laboratories, Inc. (12/21/2009)
- Paonta Sahib, India (6/15/2006)
- Princeton, NJ (10/11/2002)