Industry Wants FDA to Improve Inspection Communication, Integration

Generic drug makers would like a single point of contact for all four offices involved in inspections, an industry official told the GPhA Fall Technical Conference.

Those offices include the Office of the Commissioner, the Office of Regulatory Affairs, the Office of Process and Facilities and the Office of Surveillance, said Siva Vaithiyalingam, head of North American regulatory affairs for Cipla.

Combined GMP and pre-approval inspections complicate communication with the FDA, because drug sponsors aren’t sure who to contact within the agency to learn the status of their establishment inspection reports, Vaithiyalingam said.