A B. cepacia contamination recurrence led the US FDA to double down on sterility assurance of water systems in 2022, a trend likely to continue, Part 7 of our series finds. Open cleanroom contamination continued to drive warning letters as Annex 1 policy revision adds incentives to separate workers from injectable drug products with access barriers or isolators.

Warning letters examined in part five of our in-depth report showed how prescription drug firms got into trouble with the US FDA in 2022 by conducting investigations that were too narrow and that failed to trigger appropriate corrective actions. Several firms failed in their sterile injectables contamination investigations. Other inquiries failed to establish proper control of tablet and capsule manufacturing.

The FDA believes conducting a pre-submission meeting when a complex generic application has unusual elements can increase the likelihood of a first-cycle approval.