Sun Pharmaceutical has struggled to meet FDA expectations for the manufacturing lines at its key launch plant in Halol, India. The struggles continue.
In fact, it took the plant seven years to gain approval for a design plan change for some of its equipment, but the agency has now faulted Sun for not keeping track of the history of the project. The disclosure was laid out in a new Form 483 for the facility posted last week that includes four observations.
The inspection also faulted the plant for the fact that employees introduced unapproved processes onto a filling line that led to the failure of a portion of a batch as well as equipment issues and a new data concern, the report said. Management promised to fix the issues.
But the FDA has been finding and Sun Pharma has been fixing issues for years now, a perpetual back and forth that has kept the plant from living up to its potential for drug launches and keeping the drug manufacturer from meeting lofty financial expectations since becoming India's largest drug manufacturer in 2012.
The issues first crept up in 2014, and then the plant in 2015 was savaged in a warning letter that found a host of problems including data integrity concerns. The millions of dollars and years of effort Sun has since invested in remediation of the plant finally paid off last year when the FDA granted it an Establishment Inspection Report indicating issues has been resolved enough for the plant to move forward. That was followed last year by an FDA approval of a novel glaucoma drug to be made at the Halol plant.
In the meantime, the entire U.S. generics market that had been Sun’s go-to money maker has changed, dampening sales of already approved products. More recently, the company has been embroiled in investor backlash over alleged insider dealing by one of its directors.