The US Food and Drug Administration (FDA) raised concern on 13 January 2014 over Ranbaxy for not maintaining its Toansa plant in line with the required standards.
The FDA issued the Form 483 to drug major Ranbaxy Laboratories. FDA claimed that equipment maintenance programmes at Toansa plant were not appropriate. Also the sampling plans and procedures were not scientifically sound. The plant was found to be deficient in ensuring the quality of raw materials in line with established standards of quality.
More than 70% of active pharmaceutical ingredients (APIs), or raw materials, used by Ranbaxy in finished drugs are manufactured at the Toansa plant in Punjab, India.
Currently, drugs from Ranbaxy’s key formulations plants in India in Dewas, Paonta Sahib, Batamandi and Mohali are barred from the US market because of quality control issues.
Form 483 of FDA
Form FDA 483, is a form used by the US Food and Drug Administrator (USFDA) to document and communicate concerns discovered during inspections from the companies indulging in manufacturing over public health.
However, it does not mean the regulator has concluded that the unit is guilty of manufacturing malpractices or has banned products from them.
Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management.
A recipient of a 483 should respond to the FDA, addressing each item. While a response is not compulsory, a good response can usually help a company avoid receiving a Warning Letter from the FDA.
If you have any Question/Point on the above information, please ask/discuss it in the Current Affairs Group.