The US Food and Drug Administration (US FDA) has issued a letter to Hyderabad-based Sipra Labs, a department of scientific and industrial research (DSIR) approved Contract Research Organization (CRO), warning it about violations of current good manufacturing practice (CGMP) regulations.
The FDA had inspected the contract-testing laboratory between February 24 and March 1, 2014. The company is engaged in drug development support services to over 500 international and domestic pharma companies.
Sipra Labs CMD V Satyanarayana told FE the company has received the letter which has sought additional commitment on actions. “We have responded and taken actions, and every method will be validated,” he said.
The firm’s clientele include big pharma companies such as Sanofi Aventis, Johnson & Johnson, Glenmark, Lupin, Pfizer, Alembic and Dr Reddy’s among others.
The company had responded to the FDA observations, but FDA said it lacked sufficient corrective actions. “Our previous inspections of April 2009 and September 2011 found that methods used by your firm to test products had not been verified or validated,” the Letter said.
With the increasing number of FDA inspections in last few years, pharma analysts point out that over 20 letters were issued by US FDA to international and domestic pharmaceutical companies last year. Apart from warning letters, inspectional observations such as Form 483s, import alerts, statement of non-compliance with GMP have been issued by the global regulator. There are also instances of lapses on data integrity.
