Mumbai: Indoco Remedies Ltd Friday said the US Food and Drug Administration (FDA) has issued a warning letter to its 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, Indoco Remedies said in a stock exchange filing, adding that none of the observations pertained to data integrity.
“Based on the review of compliance response, FDA accepted our response to four observations. However, FDA remains concerned with respect to two observations, pertaining to one specific product, for which we are contract manufacturer, for one of our customers and consequently we have received a warning letter,” the company said.
In the Form 483 available on the US FDA’s website, the drug regulator observed that batch failures were not investigated properly; the quality control unit lacked authority to reject or approve all drugs and did not fully follow procedures; no procedures were established and followed to prevent microbial contamination and equipment systems and facilities were not appropriate.
Indoco Remedies said it was fully committed in resolving the issue and will respond to the queries at the earliest. “We continue to supply products from the above mentioned facility to meet our obligations to our customers and the patients in the US,” the company said.
On Friday, shares of Indoco Remedies ended down 1.2% at Rs249.95 on the BSE, while benchmark Sensex index closed down 0.1% at 29620.50 points. The company’s announcement came after the market closed.
