FDA warns Emergent BioSolutions over GMP violations at Camden facility

Regulatory NewsRegulatory News
| 16 August 2022 | By Jeff Craven 

The US Food and Drug Administration (FDA) issued a warning letter to Emergent BioSolutions subsidiary Cangene BioPharma outlining violations of current good manufacturing practice (CGMP) regulations found during a February 2022 inspection of their Camden manufacturing facility in Baltimore.
 
In the warning letter, FDA said Emergent did not appropriately clean and sanitize equipment at the facility “to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements,” and did not create written procedures on cleaning and maintaining the equipment.
 
The company also did not use proper equipment for aseptic manufacturing, which caused particulate contamination of drug products, the agency said. Specifically, one investigation found metal particulates in seven vials and silicone particulates in one vial. Emergent investigated the issue and discovered it was related to tray units with apparent damage.
 
FDA said Emergent’s documentation on inspecting the tray units prior to use “lacked specificity” on this process, such as how trays would be repaired and replaced. Emergent also did not respond with how trays would be tracked overall, actions taken for trays in need of repair or replacement, and that the tray units “are suitable for their intended purpose.”
 
Emergent’s response did not contain information on how the company will investigate cases of potential particulate contamination, the agency said. “You do not commit to accurately define and categorize intrinsic and extrinsic particulates in your operation, and to properly evaluate visible particulate contamination in your parenteral products,” FDA wrote. “It is important that intrinsic visible particulate contamination is appropriately evaluated and investigated. In addition, extrinsic or foreign particulate contamination should occur very infrequently and be thoroughly investigated.”
 
During Emergent’s inspections at its Camden facility, FDA said its investigators observed operators using poor aseptic sterilization techniques, such as leaving filling cabinets open, improperly manipulating vial tray containers and their chargers, and “leaning into the aseptic filling cabinet which caused blockage of the unidirectional airflow over open glass vials.”
 
“To safeguard sterility of the drug product in aseptic processing operations, you must establish robust operational design and procedures, and personnel must employ strict discipline. The poor aseptic techniques observed during the inspection could cause potential breaches in sterility assurance,” the agency wrote.
FDA said Emergent explained they were taking steps to improve their program of training and monitoring personnel responsible for aseptic sterilization, but the agency said that response was inadequate because Emergent did not conduct a risk assessment or provide documentation of how the company intends to monitor the program.
 
“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accordance with CGMP,” FDA wrote. “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and products manufactured by your firm conform to FDA requirements.”
 
The agency recommended Emergent hire a CGMP consultant to become compliant with CGMP requirements. The company has 15 working days to respond with how it intends on addressing the violations in FDA’s letter.
 
“Correct any violations promptly. Failure to address this matter promptly and adequately may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts,” the agency wrote.
 
History of manufacturing problems
 
This isn’t the first time Emergent has run into trouble with the FDA related to its manufacturing practices. In April 2021, the agency ordered Emergent to stop the manufacturing of any new material at its Bayview facility until it corrected quality issues at the plant mainly due to failures associated with preventing cross contamination and appropriately cleaning the facility.
 
Johnson & Johnson and AstraZeneca contracted Emergent to manufacture their COVID-19 vaccines shortly after a contract by the Department of Health and Human Services Biomedical Advanced Research and Development Authority was awarded to the company. However, 15 million doses of Johnson & Johnson’s COVID-19 vaccine were destroyed at the facility in March 2021 due to a mix-up of ingredients. (RELATED: FDA finds mess of sterility problems at Emergent, Regulatory Focus 21 April 2021)
 
In a hearing held by the US House of Representatives in May 2021, lawmakers strongly criticized Emergent for its contamination and cleanliness problems at their Bayview facility (RELATED: Legislators blast Emergent officials at House hearing, Regulatory Focus 19 May 2021)
 
“The Committees’ investigation raises troubling new questions about the lucrative contract Emergent received under the Trump Administration, the company’s failure to address manufacturing problems that led to the decision of millions of desperately needed coronavirus vaccines, and large bonuses paid to top executives despite these failures,” Rep. Clyburn and Rep. Maloney stated in a memo released at the time.
 
Rep. Clyburn and Rep. Maloney revealed last week that up to 525 million doses of Johnson & Johnson’s COVID-19 vaccine may have been wasted due to quality deficiencies at Emergent’s Bayview facility.
 
Emergent’s response
 
In response to FDA’s current warning letter, Emergent said it had retained a third party to help review their Camden facility in Baltimore and provide oversight for the processes associated with product release.
 
“Biopharmaceutical manufacturing is complex, and the stakes are high. That is why we have made significant investments to upgrade our physical capabilities and are focused on strengthening our culture of quality and compliance. This is a process that doesn’t happen overnight, but one to which we are committed,” the company said in a statement.
 
Warning Letter

 

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