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Regulatory Focus™ > News Articles > FDA Issues Form 483 for Lupin's Goa Facility

FDA Issues Form 483 for Lupin's Goa Facility

Posted 28 April 2017 | By Michael Mezher 

FDA Issues Form 483 for Lupin's Goa Facility

The US Food and Drug Administration (FDA) has issued an inspection report to major Indian generic drugmaker Lupin Limited following an inspection of its Goa, India facility earlier this month.

The Form 483 details three observations made by FDA investigators during an inspection conducted 27 March–7 April 2017, and comes roughly a year after the company reported receiving nine observations from an earlier inspection of the facility.

According to Lupin's website, the Goa facility produces solid oral formulations of drugs intended for the US market and has been inspected by FDA six times in the past, and undergone multiple inspections by the UK's Medicines and Healthcare products Regulatory Agency and the World Health Organization.

Form 483

FDA's investigators say that Lupin failed to "thoroughly review any unexplained discrepancy" of certain batches or components of its drugs, regardless of whether they had been distributed.

Specifically, the agency says the company invalidated a number of out-of-specification results without adequate justification or scientific evidence to back the conclusion. FDA goes on to detail eight such cases in the 483.

In the next observation, FDA says the facility had "no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess."

According to the investigators, hold-time studies conducted at the facility were deficient, as the batch sizes used in the studies were not representative of the company's commercial batch size.

Additionally, FDA says the company had "not conducted any retrospective evaluation of the need to repeat [redacted] Hold Time studies," despite conducting around 20 investigations related to assay failures since 2015.

In its final observation, FDA says Lupin relied on an in-process test system for tablets destined for the US market that could be reset during testing without recording the event.

During the inspection, FDA said it asked Lupin employees to hit the reset button during test sequence for a batch of tablets. "The [supervisory control and data acquisition] SCADA system did not log the reset event and no printout was recorded for the partially completed tests," FDA writes.



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Tags: Form 483, Lupin