The statement details a number of deviations from good manufacturing practices (GMP) observed during an inspection of the facility in Gandhidham, Gujarat in January.
Criticism focuses on quality control systems used at the facility which – according to Medicines and Healthcare Products Regulatory Agency (MHRA)– are not sufficient to ensure that patient safety is protected.
The UK watchdog also said systems designed to detect cross contamination “could not assure adequate assessment.” It also criticised Rusan’s packaging operations and its staff training programmes.
The firm did not respond to a request for comment.
Rusan has been criticised by regulators before for quality oversight.
In April 2011 the EDQM suspended CEPs for four products: naltrexone hydrochloride, buprenorphine, fentanyl, and buprenorphine hydrochloride following a manufacturing inspection.
A year later the MHRA issued the Gandhidham site with a letter of non-compliance. The firm has not supplied any products to the UK since November of that year.
According to Rusan’s website activities at the Gandhidham facility – which is 792km north of Mumbai in the Kandla Special Economic Zone – include the production of tablets, capsules and injectable drugs.
Also, according to Rusan the facility was designed as per US FDA guidelines and has approval from MCC - South Africa and MCAZ - Zimbabwe.