Indoco Remedies gets warning letter from USFDA for oral dosages plant in Goa
The company has received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the inspection carried out in January 2019
Indoco Remedies has received a warning letter from the US health regulator for its oral dosages facility in Goa. The company has received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the inspection carried out in January 2019, Indoco Remedies said in a filing to the BSE.
“The company will respond to the warning letter within stipulated time and is already working with current good manufacturing practice (cGMP) consultant to ensure that the remediation activities are completed in line with the USFDA’s expectations,” it added.
“We have already done considerable remediation work and shall continue to implement necessary additional corrective actions”, Aditi Kare Panandikar, MD, Indoco Remeides, said. “The company is committed to being cGMP-compliant and supplying quality products to its customers and the patients across the globe,” she added.
Indoco Remedies, however, did not disclose the issues raised by the regulator in its warning letter. The facility had received six observations in Form 483s and was classified as ‘OAI’ (official action indicated’) in March, 2019, the filing stated. The company responded to these observations with a detailed remediation plan, the implementation of which is still on-going, it said. The company has one approved abbreviated new drug application (ANDA) from this site, the annual revenue of which is around Rs 3 crore. There are four pending ANDAs from this facility and these approvals may be withheld till all the issues are resolved, it added.