FDA investigators found serious violations at Sun Pharmaceutical’s Halol, Gujarat facility during a June 3-11 inspection including a substandard media fill.
The agency officials discovered that the facility used procedures during the run that were either not accurately recorded or were not conducted according to the written batch instructions. In one instance, personnel performed maintenance to repair or reset a component of the filling station, resulting in the intake of air instead of media delivery.
The firm also used unacceptable design plans for an injectable drug that was approved in May of this year. The facility started using the design activities in August 2012 but could not demonstrate that it conformed to requirements, the agency said.