First-Time OTC Facility Inspections Drove US FDA Warning Letter Surge In FY 2019
The good news: 75% of firms not previously inspected were in compliance with US drug GMP requirements; the bad news, 25% weren't. CDER Office of Manufacturing Quality director Francis Godwin says FDA remains concerned about vulnerabilities in supply chain when OTC firms don't test products for impurities that have harmed and killed consumers in the past.
You may also be interested in...
Agency acknowledged burden regulations for implementing GMP provisions of FD&C Act placed on API manufacturers in regulatory burden notice.
Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.
The US FDA’s concerns about the transparency of the pharmaceutical supply chain surfaced in three recent drug GMP warning letters to drug repackers of active pharmaceutical ingredients who failed to disclose the names of the API manufacturers to their customers. Janet Woodcock, director of the agency's drug center, called such lack of transparency a "real threat" to public health that must be addressed quickly.