Inspectors from Regierung von Oberbayern - the Bavarian regional Government – who audited the facility on September 7 made six “major observations” according to a statement issued to the Bombay Stock Exchange (BSE) last Friday.
Dr Reddy’s said it plans to submit a corrective and preventative action plan (CAPA) adding that “the auditor has cautioned that the facility will receive EU-GMP certification from the regulator upto November 2018 only when the regulator approves the CAPA.”
The firm also said that no pharmaceutical products made at Duvvada plant are currently exported to European Union (EU) member states.
The news comes just a month after inspectors from the same German agency refused to renew the good manufacturing practice (GMP) certificate for Dr Reddy’s plant in Bachupally, Hyderabad.
The Duvvada facility – which formulates cancer drugs – has also been criticized by the US Food and Drug Administration (FDA) on several occasions.
In 2015, the agency issued Dr Reddy’s with a warning letter about operations at the site.
And FDA auditors who visited to re-inspect the facility in March this year issued the firm with a Form 483 detailing 13 observations.