FDA cites another Sun Pharma unit for GMP violations

pharmafile | September 7, 2010 | News story | Manufacturing and Production |  Sun Pharma, manufacturing compliance 

Sun Pharmaceuticals’ manufacturing operations have been found wanting by FDA for the second time in recent months, once again for one of its US facilities.

Inspections by US regulators of Sun’s production plant in Cranbury, New Jersey, between February and April this year revealed a number of violations, while corrective actions proposed by the company in May failed to meet the agency’s requirements, according to a warning letter published on the FDA website.

The most unusual defect recorded by the FDA involved bottles of gemfibrozil tablets that imploded whilst in storage on pharmacy/wholesaler shelves. Sun failed to carry out a proper investigation of the incident, says the agency.

FDA inspectors also took issue with the Indian drugmaker’s written procedures for production and process controls, and highlighted problems caused by a change in the supplier of an excipient (magnesium stearate), as well as out-of-specification impurity tests.

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Other products affected by quality defects included promethazine HCl tablets (out-of-spec water content), nimodipine capsules (leaking and sweating) and oxycodone tablets (under-filled bottles).

Sun said the FDA may withhold approval of pending drug applications listing Cranbury as the manufacturer until the violations have been rectified.

Last year, US Marshals working on behalf of the FDA seized active pharmaceutical ingredients (APIs) and finished products with an estimated value of around $20 million from another Sun Pharma unit – Caraco Pharmaceutical – after a series of manufacturing quality violations.

In June the company got a green light from the FDA for its plan to get Caraco’s manufacturing facility in Michigan back on track.

In a statement to discuss the latest action, Sun said it had taken “immediate corrective actions” and intends to respond to the FDA’s warning letter – dated August 25 – within 15 days.

The company has not made any changes to its sales forecasts for 2010-11 as a result of the FDA action.

Phil Taylor

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