The US Food and Drug Administration (FDA) found eight lapses, including presence of ‘too numerous to count flies’ and melting ice near sample storage containers, at Ranbaxy’s Toansa (Punjab) facility.
Incidentally, some of the violations, the inspection team said, were pointed out by the regulator in an earlier inspection in Dec, 2012. It even issued a Form 483 highlighting violation of norms, which serve as the primary regulatory safeguard for drug manufacturing. But even after a year, Ranbaxy failed to take measures, forcing the FDA to issue a consent decree of permanent injunction on the unit.
Toansa is Ranbaxy’s fourth manufacturing facility facing the import ban. “Appropriate controls are not established over computerized systems...This is a repeat observation from the previous FDA inspection in 12/2012,” the inspection said in its report on January 11.