According to USFDA documents sent to Ranbaxy's Mohali plant head after a series of inspections in 2011 and 2012, the US health regulator made 11 observations citing various violations of current good manufacturing practices (cGMP). (Agencies)
"There is a failure to thoroughly review any unexplained discrepancy in the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed," the USFDA said.
Citing an example, the USFDA observed that in August 2012 it was concluded that a "black fibre embedded in a tablet" was likely either "tape remnants on the nozzle head of the machine or a hair from an employee's arm that could be exposed on loading the machine".
"The firm did not conduct any analysis of the fibre to support these root causes. Further, a plan to evaluate whether the corrective actions of trimming the tape and implementing longer gloves for employees were effective was not established," it added.
Comments from Ranbaxy Laboratories could not be obtained as a query remained unanswered. Earlier, it had however said it "will review the details and will continue to fully cooperate with the US FDA and take all necessary steps to resolve the concerns at the earliest".
Pointing out further cGMP violations, the USFDA said in response to the presence of black spots observed during tablet compression, "the investigation did not include chemical analysis of the tablet or contaminated tablets to support the absence of contamination and the root cause, which was determined to have originated from oil in the compression machine."
The USFDA also pointed out the lack of hygiene in the toilet complexes of the plant.
"During the course of the inspection, the toilet facility adjoining change room of the raw material storage area did not have running water for hand washing and toilet flushing," it said.
Stating that washing and toilet facilities lacked hot and cold water, USFDA further said: "Additionally, there are no procedures to direct employees to wash hands with soap and water after toilet use and prior to gowning..."
Mohali (Punjab) is the company's third plant to come under the USFDA import alert after the Dewas (Madhya Pradesh) and Paonta Sahib (Himachal Pradesh).
In May, Ranbaxy pleaded guilty to "felony charges" related to the manufacture and distribution of certain 'adulterated' drugs made at two units in India and agreed to pay USD 500 million to US authorities as a penalty.
This followed a series of actions by the US authorities and the FDA, which in 2008 banned the import of 30 generic drugs produced by Ranbaxy at its Dewas and Paonta Sahib plants for violation of manufacturing norms.
According to USFDA documents sent to Ranbaxy's Mohali plant head after a series of inspections in 2011 and 2012, the US health regulator made 11 observations citing various violations of current good manufacturing practices (cGMP).