US Food and Drug Administration (FDA) has issued a warning letter to Indoco Remedies Ltd’s manufacturing plant in Goa for violation of good manufacturing practices.
The US drug regulator had inspected the plant between 31 August and 4 September, 2016 and made six observations relating to deviation from norms.
It received six observations, which do not pertain to data integrity. While the U.S. FDA accepted Indoco’s response to four, the regulator issued a warning letter on two observations over good manufacturing practices requirement, the company said.
The two observations pertain to opthalmic drug Latanoprost, for which the company is a contract manufacturer.