Ranbaxy Laboratories suffered a fresh setback as the
US Food and Drug Administration (FDA) banned drug imports from the company's Toansa factory, citing manufacturing violations.
"The FDA's inspection of the Toansa facility, which concluded on January 11, identified significant CGMP violations," the FDA said in a press release on Thursday.
CGMP refers to current good manufacturing practices. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality.
"These [violations] included Toansa staff retesting raw materials, intermediate drug products, and finished API (active pharmaceutical ingredients) after those items failed analytical testing and specifications, in order to produce acceptable findings, and subsequently not reporting or investigating these failures."
The move is significant because the Toansa facility supplies two-thirds of the company's APIs needs.
Ranbaxy has been under the FDA's radar for quite some time. In May last year, the company pleaded guilty to felony charges relating to manufacture and distribution of adulterated drugs made at two factories and agreed to pay $500 million to settle charges.
The FDA said Ranbaxy will now be required to hire a third-party expert to inspect the Toansa facility in Punjab and certify to the regulator that the facility and its methods comply with good manufacturing practices. "Ranbaxy will not be permitted to resume manufacturing and distributing API for FDA-regulated drugs from the Toansa facility until the agency is satisfied that Ranbaxy has addressed its manufacturing quality issues at that facility," it said.
The FDA also said that the Toansa facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012. The decree contains provisions to ensure compliance with CGMP requirements at Ranbaxy facilities at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh, as well as provisions to address data integrity issues at those facilities. In September 2013, the FDA added Ranbaxy's Mohali facility in Punjab to the CGMP provisions of the decree.
The FDA said it exercised its authority under a provision in the consent decree which permits the agency to extend the decree's terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the federal Food, Drug, and Cosmetic Act or FDA regulations. The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that it determines are necessary to achieve compliance with the law or the decree.
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