Drug firm Alkem Laboratories today said it has received establishment inspection report (EIR) from the US health regulator on the closure of its inspection at its API facility at Ankaleshwar in Gujarat.
"The US FDA has issued an establishment an inspection report (EIR) for company's Active Pharmaceutical Ingredient (API) manufacturing facility located at Ankaleshwar, India which was inspected in December, 2016. The inspection has now been closed by the US FDA," the company said in a filing to BSE.
The company has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The US FDA has reviewed the CAPA and has found them acceptable.
Alkem Laboratories had in December said that the US health regulator has issued three observations after inspection of the company's API facility at Ankleshwar in Gujarat.
"United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s API (Active Pharmaceutical Ingredient) manufacturing facility located at Ankleshwar from 5th December to 9th December, 2016," Alkem Laboratories had earlier said in a filing to BSE.
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