US FDA recommends Lupin ‘assess its global manufacturing operations’
The US Food and Drug Administration (FDA) has made public a warning letter delivered to Lupin regarding inspections that took place between November 26 and December 5, 2018, at its Mandideep, India site.
The conclusions of the inspection saw the FDA highlight concerns over Lupin’s overall ability to maintain current good manufacturing practices (cGMP), mentioning that it had issued similar observations on its Goa and Indore facilities.
In the warning letter, the agency told Lupin, “These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs are inadequate. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products you manufacture conform to FDA requirements.”
In particular, at Lupin’s Mandideep facility, the agency narrowed down on three violations: the failure to fully investigate unexpected discrepancies or failure of batches; the failure to establish adequate written procedures for production and process control; and, the failure to clean, maintain and sanitize/sterilize equipment.
On the latter finding, the agency noted that its inspectors discovered a tablet press labelled as cleaned, despite there being ‘unknown residues’ on product contact surfaces.
Last month, Lupin acknowledged the delivery of the warning letter and stated, “The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues for operations of this facility.”
The company continued to say that it is working with the FDA to resolve the issues.
Earlier this year, the company received a Form 483 from the agency, after human hair was discovered contaminating product, and, at the end of the previous year, a number of observations were noted regarding the same Mandideep site.
At the time of writing, shares in Lupin were down 8% from prior to the publication of the warning letter.