Alkem Laboratories has said that the USFDA has issued three observations after inspecting the company’s API facility at Ankleshwar in Gujarat.
Alkem Laboratories has said in a BSE filing that “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”.
It added that the company has got the inspection report which contains three 483 observations.
