A report prepared by inspectors of the US Food and Drug Administration has cited as many as eleven discrepancies in the processes followed by Ranbaxy at its Mohali plant leading to the drug import ban.
This includes presence of a black fibre in a tablet suspected to be hair from an employee’s arm and lack of written procedures for production and process controls designed to assure quality. Lack of running water for washing hands and toilet flushing has also been reported by US FDA inspectors.
“A black fibre embedded in a tablet was likely either 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,” stated the eight-page report seen by
The inspection by the FDA, done in September 2012, also found black spots in tablets during tablet compression (a process that compresses powder into tablets of uniform size and weight.). The report said that Ranbaxy did not do chemical analysis of the tablet to rule out contamination, which may have originated from oil in the compression machine.
“Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. Specifically, your firm does not always establish adequate process controls and product specifications,” the US FDA report said.
During the course of the inspection it was found that toilet facilities adjoining change room of the raw material storage area did not have running water. The water supply was reportedly turned off during maintenance and inadvertently left off. “There are no procedures to direct employees to wash hands with soap and water after toilet use and prior to gowning, and no adequate facilities and procedures for employees to wash their feet prior to donning factory-issued work sandals,” it said.
The FDA has also questioned Ranbaxy’s capability to investigate and report discrepancies. For example, investigations were initiated by the company on two specific complaints lodged by pharmacies between July 17 and August 17, 2012. But the company did not extend the investigations to other batches of the same drug product, the report noted.
Ranbaxy did not respond to the specific observations made by the US drug regulator. On Tuesday, the company had said it would review the details of the FDA import alert and take all necessary steps to resolve the concerns.
Mohali is the company’s third unit to come under the FDA import alert after the Dewas (in Madhya Pradesh) and Paonta Sahib (Himacha Pradesh) plants. Ranbaxy, which is 63.5 per cent-owned by Japan's Daiichi Sankyo Co, gets more than 40 per cent of its sales from the US.