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Lupin under quality violations scanner by US FDA

Lupin under quality violations scanner by  US FDA

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,”

Source: self
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