US FDA seizes drugs from Sun Pharma subsidiary Caraco
26 Jun 2009
The US Food and Drug Administration (FDA) on Thursday raided Caraco Pharmaceutical Laboratories, the US subsidiary of Indian specialty drugs major Sun Pharmaceutical, and seized 33 drugs made by the company.
The FDA sent in marshals to seize drug products manufactured by Caraco at the company's Detroit, Farmington Hills, and Wixom, Michigan facilities and temporarily ceased all manufacturing, an FDA release said.
The FDA also seized ingredients held at these facilities, alleging that the company continued to fail to meet the FDA's current good manufacturing practice (cGMP) requirements, the FDA said.
"FDA inspections of Detroit, Michigan-based Caraco have documented serious repeat violations of cGMP regulations from 2005 onwards. The most recent inspection, which ended in May 2009, revealed serious deficiencies in the control of the company's manufacturing practices," the FDA said.
Since January 2009, Caraco has recalled a number of products due to manufacturing defects, including Digoxin tablets, a drug used to treat heart failure and abnormal heart rhythms, since the tablets were oversized, the FDA added.
The FDA said some of the violations were repeats of 2005, 2006, and March 2008 and yesterday's inspection and seizure was intended to lead to major changes at Caraco's facilities.
Through this seizure, the FDA said it seeks to immediately stop the firm from further distributing drugs until there is assurance that the firm complies with good manufacturing requirements.
Sun Pharmaceutical invested an initial $7.5million and structured a technology transfer agreement with the loss making Caraco in 1997. The company had a sales turnover of $0.8 million in 1997.
In 2000, Sun Pharmaceutical assisted Caraco in obtaining loans from ICICI Bank and the Bank of Nova Scotia to the tune of $5 million each. Out of these loans, Caraco utilised ICCI Bank's $5 million and $3.85 million from Bank of Nova Scotia during the year. (See: Will the 'Sun' rise on Caraco Pharmaceuticals?)