Indian pharmaceutical company Dr Reddys Laboratories informed that German regulatory authority has issued six major observations against its formulations unit at Visakhapatnam in Andhra Pradesh after an inspection.
“The Regulatory Authority of Germany (Regierung von Oberbayern) concluded an audit of our formulations facility in Duvvada, Visakhapatnam with zero critical and six major observations,” Dr Reddys Laboratories said in a Bombay Stock Exchange (BSE) filing.
The products manufactured at the facility are currently not exported to the European Union, it added.
“The company will be submitting a Corrective Action and Preventive Action (CAPA) Plan to the authorities. The auditor has cautioned that the facility will receive EU-GMP certification from the regulator up to November 2018 only when the regulator approves the CAPA,” Dr Reddy’s said.
The facilitys compliance with the CAPA and other applicable regulations will be reviewed again by the regulator by November 2018 for continuation of EU-GMP certification, it added. The company had earlier received 13 observations from the US health regulator, FDA, for its formulations manufacturing facility at Duvvada, Visakhapatnam in March this year.