USFDA plant inspections seem to be coming back strongly after a two-year hiatus, going by the just-concluded inspection at Zydus Lifesciences on March 10 and a warning letter to Aurobindo earlier this year, in mid-January.
USFDA officials commented in February 2022 that USFDA is keen on restarting pharma companies inspections, including surprise inspections in India.
USFDA could be set for a busy year in India as the backlog of redressals from previous inspections and pending applications for plants and products become pressing.
Earlier, the total number of USFDA plant audits for drug quality assurance in India peaked in 2019 at 239.
Another 80 inspections were completed in January-March 2020 prior to Covid and slid to 5 inspections in 2021.
The surge in audit inspections could be periodic or could also be linked to evolving standards in manufacturing.
