Drugs

Emergent BioSolutions Hit with FDA Warning Letter

FDA has issued Emergent BioSolutions an 8/10 Warning Letter citing the firm’s Camden, MD manufacturing facility based on a February inspection. The 87,000-sq. ft. contract manufacturing facility in Baltimore provides drug product manufacturing for sterile injectables, according to the company. It offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.

Emergent says the letter cites two deficiency areas:

systems for cleaning and maintenance of equipment to prevent contamination of drug products, specifically related to particulates from metal trays, and
processes and practices surrounding aseptic processing.

In addition, the agency recommended the company review and assess its quality management system and retain a GMP consultant to help address the issues.

“While waiting for FDA’s response related to a February 2022 inspection of the facility, the company retained a third party for additional review of the facility and to provide additional oversight of processes for product release,” Emergent says. “The company remains committed to upgrading its physical capabilities and strengthening its culture of quality and compliance.”

In May, a staff report prepared for the House Committee on Oversight and Reform and the House Select Committee on the Coronavirus Crisis detailed manufacturing issues at Emergent’s Bayview (Baltimore) vaccine manufacturing facility. It noted that the issues led to hundreds of millions of taxpayer dollars being wasted and affected the country’s ability to meet the urgent need for Covid-19 vaccines earlier in the pandemic.

The report made these points:

Emergent hid evidence of contamination from FDA inspectors and company officials strategized how to evade questions from HHS;
nearly 400 million doses of coronavirus vaccines have been destroyed as a result of the company’s failure to meet or maintain quality standards;
Emergent executives promoted the company’s manufacturing capabilities despite being warned of severe deficiencies;
FDA, Johnson & Johnson, and AstraZeneca identified multiple deficiencies at Bayview that Emergent failed to remediate despite urgent warnings;

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