USFDA issues warning letter to Mumbai-based Aarti Drugs

Failure to correct violations may result in FDA refusing admission of articles manufactured by Aarti Drug Ltd into the US

US health regulator has issued a warning letter to Mumbai-based Aarti Drugs, saying it is not satisfied with the company's response to its inspections at the company's Maharashtra facilities and noted that they lack sufficient corrective actions.

The investigators of the US Food and Drug Administration had identified significant violations of current good manufacturing practise (CGMP) regulations for finished pharmaceuticals and active pharmaceutical ingredients at the companies Maharashtra facilities, the letter said.

The inspections by the USFDA were carried out between October 25 and October 30, 2012 and November 1-5, 2012, the letter written by the regulator to the Joint MD of the company added.

The significant violations were the company's failure to record all quality activities at the time they are performed and failure to review and investigate production and QC laboratory deviations, USFDA said.

The other deviations were failure to maintain laboratory control records with complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays and failure to implement access controls and audit trails for laboratory computer systems, the warning letter said.

"Until all corrections have been completed and FDA has confirmed corrections of the violations and your firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as an API manufacturer," USFDA said.

In addition, the failure to correct these violations may result in FDA refusing admission of articles manufactured by Aarti Drug Ltd into the US, it added.