The company's Unit 2 manufacturing plant in Pithampur, along with its Goa site, is under USFDA's warning letter since November 2017.
Drug maker Lupin on January 26 said it had received six observations from USFDA for its Unit 2 plant in Pithampur, Indore.
The inspection was conducted between 14 and 25 January, said the company.
The nature of these observations were not known. Lupin said it is confident of addressing the observations satisfactorily.
At the end of the 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.
The company's Unit 2 manufacturing plant in Pithampur, along with its Goa site, is under USFDA's warning letter since November 2017.
The US drug regulator, after inspecting the two sites, expressed concerns over quality control procedures that include handling of out-of-specification (OOS) results and conducting hold-time studies.
The company said it has completed remediation at both of its plants, and invited the USFDA for re-inspection.
