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news.Ranbaxy has signed a consent decree which bans the company from manufacturing drugs at certain plants for the US market until it corrects ongoing deficiencies in cGMP.
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The firm will also be banned from providing medicines for use in the President’s Emergency Plan for AIDS Relief (PEPFAR) program, according to InPharm.
As per the decree, Ranbaxy has agreed to hire a third-party expert to carry out an internal review and audit of the facilities, implement measures to ensure data integrity in the company’s drug applications.
The third party can withdraw any applications found to contain untrue statements or irregularities, according to an FDA statement.
Ranbaxy has agreed to remedy its long-running production woes at Indian sites in Paonta Sahib, Batamandi and Dewas, as well as to correct data integrity problems at numerous facilities in its network.
The FDA regulatory affairs associate commissioner Dara Corrigan said because company continued to violate cGMP regulations and falsify information on drug applications, the FDA took these actions.