FDA Unveils Extensive Manufacturing Violations at Emergent

Just in case anyone suspected FDA of over-reacting to problems at this troubled vaccine production site—or that any poor quality materials could be released—FDA officials have taken the unusual step of issuing the closeout report (form 483) on its just-completed re-inspection of Emergent BioSolutions’ Baltimore manufacturing facility. The report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

FDA acting commissioner Janet Woodcock and Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), issued a forceful statement emphasizing the importance of thorough FDA inspections and review of quality procedures to ensure product quality.¹ These FDA leaders aim to reassure the public that no vaccine will be released from the Emergent facility until FDA can assure it meets standards.

FDA inspectors found violations in last week’s inspection raise the risk of product cross-contamination and unsanitary conditions, specifically citing improper cleaning, lack of written procedures, faulty handling of raw materials and containers, and inadequate employee training to perform required job functions.² And these are many of the same issues cited in by FDA inspectors in previous site visits, indicating that Emergent has failed to address multiple ongoing problems.

The situation now has drawn attention on Capitol Hill. Leaders of the House Oversight & Reform Committee and its Select Subcommittee on the Coronavirus Crisis have opened an investigation into how Emergent lobbying and political connections may have influenced continued funding for vaccine manufacturing, despite ongoing regulatory issues.³

Woodcock and Marks emphasize that they are “doing everything we can” to ensure that COVID-19 vaccines for Americans meet FDA’s high standards for quality, safety and effectiveness. The result, they hope, is that FDA will maintain the public’s trust in its operations.

References

1. https://content.govdelivery.com/accounts/USFDA/bulletins/2ce64ec
2. https://www.fda.gov/media/147762/download?utm_medium=email&utm_source=govdelivery
3. https://coronavirus.house.gov/news/press-releases/maloney-and-clyburn-launch-investigation-emergent-biosolutions-profits-and