Lupin is served with two observations from US FDA for Pithampur unit

▴ Lupin
FDA observations for Lupin though it passed the other regulatory benchmarks

Pharma major Lupin Limited (Lupin) who announced, the successful completion of the inspection carried out by the UK Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory agency of the United Kingdom (UK) at its three manufacturing units in Pithampur (India) got two observations from FDA.

According to Lupin,US health regulator has issued two observations after inspection of the company’s Madhya Pradesh facility. The inspection of the company’s Pithampur Unit-I facility by the United States Food and Drug Administration (US FDA) has been completed, Lupin said in a filing to BSE.

The inspection carried out between February 3 and February 11, 2020, closed with two 483 observations, it added. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts. It notifies the company’s management of objectionable conditions at the facility.

“We uphold the highest standards of quality and compliance across our manufacturing operations and are committed to consistently produce and distribute products of the highest quality,” Nilesh Gupta, MD, Lupin said

The inspection for the three units at Pithampur closed with no critical observation and one major observation.

Tags : #Lupin #Usfda #2observations #Pithampurunit

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