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Last Updated : Feb 09, 2019 02:53 PM IST | Source: Moneycontrol.com

Lupin gets 2 USFDA observations for its Goa plant

Lupin's Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore are under USFDA's warning letter since November 2017.

Viswanath Pilla @viswanath_pilla
 
 
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Drug maker Lupin on February 9 said it got two observations from US drug regulator for its crucial Goa manufacturing site, which is under warning letter.

The inspection was carried out between January 28 to February 8, 2019.

"The observations are procedural in nature and the company is confident of addressing them satisfactorily," Lupin said in a statement.

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At the end of every inspection, the USFDA issues its observations on any deviations from current good manufacturing practices (cGMP) on Form 483. Companies will have to respond with corrective and preventive action plan to these observations with 15 days of the receipt of Form 483.

Lupin's Goa site, along with Unit 2 manufacturing plant in Pithampur, Indore are under USFDA's warning letter since November 2017.

Towards the end of last month Unit 2 plant in Pithampur received six observations from USFDA. Lupin's Managing Director Nilesh Gupta, in company's recent media call earlier this week said the drug maker is in the process of responding to the USFDA's observations on Unit 2.

The US drug regulator, after inspecting the two sites in 2017, and expressed concerns over quality control procedures that include handling of out-of-specification (OOS) results and conducting hold-time studies.

Lupin completed an extensive remediation at both of its plants, and invited the USFDA for re-inspection.

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First Published on Feb 9, 2019 02:52 pm
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