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Pharmaceutical major Lupin announced that the drug maker had received six observations from USFDA for its Unit 2 plant in Pithampur, Indore on 26 January.
The company said in its regulatory filing, “Pharma major Lupin announced today the completion of the United States Food and Drug Administration (U.S. FDA) inspection carried out at its Pithampur Unit -2 (Indore) facility. The inspection was carried out between January 14 and January 25, 2019.”
Lupin also added that the company is confident in addressing the 6 observations received during an inspection at Pithampur Unit-2 (Indore) satisfactorily. However, the company did not specify the nature of these observations.
USFDA, at the end of each inspection, issues its observations on any deviations from current good manufacturing practices (cGMP) on Form 483. The company is then required to respond with a corrective and preventive action plan to these observations within the 15 days.
