US FDA raises concerns over a fourth Ranbaxy facility
14 Jan 2014
The US Food and Drug Administration (FDA) has raised concerns about the manufacturing practices at a fourth plant of Ranbaxy Laboratories factory in India, escalating regulatory problems for India's largest generic drug company.
US regulators in their assessment of Ranbaxy's operations in Toansa, Punjab, listed possible violations of the US Food Drug and Cosmetic Act (FDCA) by the company.
The 'Form 483' issued by the Food and Drug Administration this week implied the discovery of ''conditions that… may constitute violations of the FDCA… (including a) drug (being) adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health''.
In a statement Ranbaxy said, ''The Company is assessing the observations, and will respond to the US FDA in accordance with the agency's procedure to resolve the concerns at the earliest.''
''On January 11, Ranbaxy received Form 483 with certain observations as a result of the recent FDA inspection at its active pharmaceutical ingredient plant at Toansa, Punjab. The company is assessing the observations and will respond to the FDA… to resolve the concerns at the earliest,'' Ranbaxy said in a filing with the Bombay Stock Exchange on Monday.
''Ranbaxy continues to improve its systems and processes, and remains fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company. Ranbaxy stays firmly committed to its philosophy of 'Quality and Patients First'.''
At the conclusion of inspection, Form 483 is presented and discussed with the company's senior management. The company is encouraged to respond with a corrective action plan followed by its implementation. Else, an import alert could be issued against the company, Ranbaxy said.
In June 2013, Ranbaxy had to pay up $500 million in fines and plead guilty to seven felonies, including criminal charges and manufacturing fraud allegations that the company made material false statements in field reports, effectively fudging its data to get approvals for generic drugs in the lucrative US market.
The Toansa plant contributes ''60 to 70 per cent of the company's active pharmaceutical ingredients'' sold in bulk to manufacturers.
Three other Ranbaxy facilities, at Paonta Sahib (Himachal Pradesh), Dewas (Madhya Pradesh), and Mohali (Punjab) are facing import alerts or restrictions from the FDA.