A company executive said on Tuesday that the US drug regulator's observations on its active pharmaceutical ingredient plant at Miryalaguda are minor and easily addressable.
The company didn‘t explain the nature of these observations. Miryalaguda plant was one among the three plants for which the company got US drug regulator warning letter in November 2015.
Drug firm Dr Reddy's Laboratories today said the US health regulator has made three observations after completing inspection of its Miryalaguda facility.
Saumen Chakraborty, CFO, Dr Reddy's Laboratories, says "The warning letter has come telling the management to respond within 15 working days in terms of strategy and plan."
The warning letter was issued by the FDA to Dr Reddy's on Thursday for its Srikakulam, Miryalaguda and Duvvada drug manufacturing plants - all based in southern India.
The warning letter is relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.