FDA Issues Warning Letter to Sun Pharma Regarding Violations of New Jersey Facility

The Food and Drug Administration has warned drug company Sun Pharmaceutical Industries Inc. that it found significant violations of current good manufacturing practice (cGMP) regulations at the company’s manufacturing facility in Cranbury, N.J. , according to a warning letter posted Aug. 31 on FDA’s website.

FDA said it found the violations during an inspection of the Cranbury facility that ended April 28. The company responded to FDA about the violations May 18, but the agency said the response lacked sufficient corrective actions.

Specific violations observed by the agency include, but are not limited, to the following:

• the facility does not ...