USFDA observations in 2022 focus on ancillary infra, written procedures

45% observations in 2022 around unavailability of written procedures and facility maintenance, ancillary infrastructure

Around 45 per cent of observations issued by the US drug regulator in 2022 were around unavailability of written procedures, facility maintenance and ancillary infrastructure, shows an analysis of Form 483s issued by the US Food and Drug Administration (USFDA), according to McKinsey.

The analysis shows that the nature of observations made in a Form 483 has been changing over the years. And, observations on issues such as laboratory control and core manufacturing processes have been on the decline.

This implies that core manufacturing processes at Indian sites are more or less stable and under control. And now, the regulatory focus is