Sun Pharmaceutical has struggled to fulfill FDA expectations for the manufacturing lines at its essential launch plant in Halol, India. The struggles continue
In reality, it took the plant seven years to gain approval for a design plan change for few of its equipment; however, the agency has now faulted Sun for not monitoring the history of the project. The disclosure was specified by a brand new Form 483 for the facility posted last week that features four observations.
The inspection also faulted the plant for the fact that staff introduced unapproved processes onto a filling line that led to the failure of a portion of a batch in addition to equipment issues and a brand new data concern, the report stated. Management promised to repair the problems.
But the FDA has been finding and Sun Pharma has been fixing points for years now, a perpetual forward and backward that has saved the plant from living up to its potential for drug launches and maintaining the drug manufacturer from meeting lofty monetary expectations since turning into India’s largest drug producer in 2012.
The problems first crept up in 2014, after which the plant in 2015 was savaged in a warning letter that found several issues together with data integrity issues. The millions of dollars Sun has since invested in the remediation of the plant finally paid off last year when the FDA granted it an Establishment Inspection Report indicating points has been resolved sufficiently for the plant to move ahead. That was adopted in the previous year by an FDA approval of a novel glaucoma drug to be made at the Halol plant.