Indoco Remedies has received a Warning Letter from the United States Food and Drug Administration (USFDA) for its Oral dosages Plant, situated at L -14, Verna Industrial Road, Goa (Plant I), as a result of the inspection carried out in January 2019. The facility had received 6 observations in Form 483s and was classified as ‘OAI’ (Official Action Indicated’) in March, 2019. The company responded to these observations with a detailed remediation plan, the implementation of which is still on-going.
The company will respond to the Warning Letter within stipulated time and is already working with cGMP consultant to ensure that the remediation activities are completed in line with the USFDA's expectations.
Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.
