Panaji:Lupin Limited’s Goa unit has come under the US FDA scrutiny for non adherence to quality control and standard procedures. The US FDA alert came just after two days of the Chief Minister Mr. Francis D ‘ Souiza ‘s notification to the Pharma industry to follow strict quality management in their respective plants, both in the interest of the consumer and the sustainability of the industry in Goa.
US FDA on Inspection of the Lupin Plant has made 9 critical observation.connected with inadequacies and adherence to standard operating procedures. Two of the observations made by US FDA were in done during an inspection in 2015. The shortcomings pointed out by USFDA included lab controls not including scientifically sound and appropriate test procedures, written procedures for cleaning and maintenance of equipment being deficient.
A Lupin Official while acknowledging the USFDA raising doubts on the 9 key issues pertaining to adherence of standard operating procedures said
“We are in the midst of putting together a response to address the US FDA’s observations.” During the inspection the USFDA found the procedures designed to prevent objectionable micro-organisms in drug products sterile and not followed in the manner they were supposed to. The apex regulatory body also found the premises used for manufacture processing, packing or holding of drug products unhygienic. The USFDA also frowned upon the manner employed by the company in the disposal of its garbage.
The Chief Minister in his address on 16 th March had praised the pharmaceutical manufacturing companies of Goa for their standards in quality maintenance adding “FDA should not be of concern, as patient safety is paramount and of utmost importance,”