Ranbaxy announced on 11 January 2014 that the Toansa plant, which manufactures around 70–75% of Ranbaxy’s active pharmaceutical ingredients (APIs), received the Form 483 with certain observations following a recent inspection by FDA.

A Form 483 is issued to companies at the conclusion of an inspection when investigators have observed conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

This could cause problems for Ranbaxy due to the fact that this is the company’s main API facility and that the company’s other India-based factories at Paonta Sahib, Dewas and Mohali are already banned from exporting drugs to the US.

Ranbaxy’s Dewas and Paonta Sahib facilities have been on FDA Import Alert since 2008, affecting both drug imports and drug applications to the US. The Mohali plant joined them in September 2013, following 2012 inspections that identified significant good manufacturing procedure (GMP) violations at the site [1].

Ranbaxy will now have to respond to FDA’s Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously. Ranbaxy stated in its press release that the company ‘is assessing the observations, and will respond to the FDA in accordance with the agency’s procedure to resolve the concerns at the earliest’.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Ranbaxy receives another import ban from FDA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jan 24]. Available from: www.gabionline.net/Generics/News/Ranbaxy-receives-another-import-ban-from-FDA

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