FDA finds hair, oil spots on tablets at Ranbaxy's unit

Last year, during USFDA's visit to Ranbaxy's Laboratory facility, inspectors found a black 'hair' particle in a tablet, possibly suspected to have fallen from an employee's arms.


USFDA has imposed 'import alert' on Ranbaxy's Mohali plant

Post this incident, the USFDA became highly alert and imposed an import alert on its Mohali plant, stating that the drugmakers manufacturing units were not up to the industrial standards. This import alert has prohibited Ranbaxy from manufacturing FDA-regulated drugs at its Mohali facility unit.

Ranbaxy said that it would review FDA's details on import alert and take necessary corrective actions to rectify the situation. In its statement, Ranbaxy said, "The USFDA had conducted inspections at Ranbaxy's Mohali facility last year (2012), resulting in certain observations. The company believes that it has made further improvements at its Mohali facility. We'll remain committed to addressing all concerns of the USFDA."

Other findings of the FDA included the use of dirty glassware, packaging line failure, dark spots on tablets from the oils from machines, abrasions on tablet surfaces and absence of running water in toilets.

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