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# Routine Vaccine Inspections May be Challenge: GAO
- URL: https://www.fdaweb.com/routine-vaccine-inspections-may-be-challenge-gao/
- Published: 2021-10-27T12:00:00.000Z
- Updated: 2026-09-14T17:20:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150456

A 10/27 Government Accountability Office oversight report on the federal government response to Covid-19 says FDA “may face challenges resuming routine surveillance inspections of vaccine and allergenic manufacturing establishments.” The agency told GAO that vaccine inspections are a priority, the [report](https://files.gao.gov/reports/GAO-22-105051/index.html?ref=fdaweb.com#Highlights) says.

It says FDA significantly reduced inspections of biologic manufacturing establishments due to the Covid-19 pandemic and identified alternative tools it could use to help oversee manufacturing quality during the emergency. The alternative tools included records requests, investigations and site visits, and remote interactive evaluations.

GAO says it spoke with representatives of biologic manufacturing associations who said they generally supported the use of alternative inspection tools, although there were some challenges. The association representatives noted a lack of communication from FDA following record requests. GAO says the agency indicated it planned to revise record request procedures in FY 2022 to increase communication with manufacturers.

GAO says a major issue in resuming inspections at vaccine and allergenic manufacturing establishments is that most of them are overseas and CBER has not set a schedule for resuming foreign inspections.