Virtual audits will not replace physical inspection, says USFDA

Virtual facility audits will continue even as the pandemic wanes and travel restrictions ease, said a senior US Food and Drug Administration (USFDA) official. Phil Nguyen, international relations specialist, USFDA, said virtual audits will not replace physical inspections of manufacturing facilities, but they will continue.

Surprise audits of manufacturing sites too are on the cards. S Eswara Reddy, joint drugs controller (India), Central Drugs Standard Control Organisation (CDSCO), said local CDSCO officials acco­m­pany USFDA counterparts in the physical inspections.

“According to a MoU that we have with the USFDA our officials also accompany during inspections, but we have the role of an observer,” he said, adding that Indian firms are always prepared for surprise audits.

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