The US Food and Drug Administration (FDA) has found a black fibre embedded in the tablets manufactured at Ranbaxy’s Mohali plant, documents available with Hindustan Times showed on Wednesday. According to documents sent to Ranbaxy by the USFDA after a series of inspections in 2011 and 2012, the US health regulator made 11 observations citing various violations of current good manufacturing practices (GMP).
When contacted, Ranbaxy did not offer any comments.
“Deviation concluded that a black fibre embedded in the tablets was likely to be either tape remnants on the nozzle head of the machine or a hair from an employee’s arm that could have been exposed on loading the machine,” the USFDA said. “The firm did not conduct any analysis of the fibre to support these root causes,” documents said.
The regulator also pointed another deviation in response to the presence of black spots in tablets during tablet compression. “The root cause was determined to have originated from oil in the compression machine.”
The USFDA had on Monday blacklisted Ranbaxy’s Mohali plant, its third factory to face such an import ban, bringing its share prices crashing by 30.3%.