Drugs

Emergent BioSolutions Warning Letter Out

FDA has released the Warning Letter issued following a 2/7-2/18 inspection of the drug manufacturing facility at Cangene BioPharma, doing business as Emergent BioSolutions, Baltimore, MD (see previous story) The 8/10 Warning Letter says specific violations were:

failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals 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 failing to establish and follow adequate written procedures for cleaning and maintenance of equipment; and
failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The letter notes that similar violations were cited in a 2021 inspection and discussed at a 10/6/21 regulatory meeting. “You responded by proposing specific remediations to address these observations,” it says. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

FDA says significant findings in the letter demonstrate that Emergent does not operate an effective quality system following CGMP. “In addition to the lack of effective operations oversight to ensure reliable operations,” it says, “we found that your quality unit was not fully exercising its authority or responsibilities. 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 recommends that Emergent engage a qualified consultant to assist it in meeting CGMP requirements.

Emergent was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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