On November 9, 2018, then FDA Commissioner Scott Gottlieb announced the agency's launch of the first in a series of new inspection protocols set to roll out over the next two years. The New Inspection Protocol Project (or "NIPP") presents a new way of assessing, recording, and reporting the data from surveillance and pre-approval inspections for sterile drug products.
Beginning with new protocols for aseptic processing drug inspections specifically, the official rollout of the NIPP is an effort to eventually make inspections of sterile manufacturing sites more consistent while also enabling the agency to better catch problems that could lead to a drug shortage.
“[T]here’s increasing need to more efficiently collect and analyze the information we gather during inspections to give us even better and timelier insight on the state of quality in drug manufacturing facilities and promote the relevance of this information to our regulatory decisions," Dr. Gottlieb said in his press release.Continue Reading
The FDA’s recent and ongoing focus on over-the-counter (OTC) drugs and other health products intensified with the agency issuing warning letters to four companies with very similar citations.
The agency referenced these findings to point out its industry-wide concern for violations it said puts consumers at significant risk. These include insufficient quality controls for potentially hazardous products and skipped safety tests that have led to potentially harmful contamination in multiple products.
While these latest crackdowns target producers of homeopathic products specifically, (an area which began attracting greater attention from regulators back in 2015) the broader OTC manufacturing field has come under greater oversight, as evident by recent inspection and enforcement trends.Continue Reading