The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / GMPs / Inspections and Audits

Ranbaxy’s Indian API Plant Added to 2012 Consent Decree

Jan. 31, 2014

Ranbaxy’s regulatory woes deepened Jan. 23 as the FDA prohibited the drugmaker’s Toansa, India, plant from manufacturing and distributing active pharmaceutical ingredients (APIs) for U.S. products after a poor inspection.

The decision makes the Toansa plant the fifth Indian facility to be subjected to limitations outlined in a 2012 consent decree, joining facilities in Paonta Sahib, Dewas, Batamandi and Mohali.

The decree prevents Ranbaxy from manufacturing drugs for the U.S. market until the FDA is satisfied the company has addressed its manufacturing quality issues. Going forward, the Ranbaxy will also have to hire a third-party expert to conduct routine audits of the Toansa facility, just like the other facilities.

The drugmaker has 21 manufacturing facilities spread across 8 countries. The trouble at Toansa came to light in an inspection of the plant earlier this month that prompted a Form 483.

The inspection found significant violations of good manufacturing practices (GMP) such as retesting raw materials, intermediate drug products and APIs that failed analytical testing to produce a passing result. The plant also failed to report or probe those failures, the FDA said.

Since agreeing to the consent decree, Ranbaxy has moved to implement quality enhancements to satisfy the FDA. Its U.S. subsidiary Ohm Laboratories supplies a majority of Ranbaxy’s prescription and OTC products in the U.S. Ohm’s New Brunswick, N.J., facility was able to resolve GMP violations from a 2012 inspection.

Ranbaxy said earlier this month on its website that it will respond to the FDA’s concerns in the Form 483 and continue to improve its systems and processes.

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