STAT+: FDA declares Novo Nordisk plant, key to drug manufacturing for some biotechs, out of compliance
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A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the Food and Drug Administration standards, a serious designation that could further delay the approval of drugs made in the facility, including some from Scholar Rock and Regeneron Pharmaceuticals.<\/p>\n
STAT previously reported<\/a> that an FDA inspection of the plant over the summer found a litany of issues, some related to cat hair, pests, and equipment failures. Last week, the agency told Novo that the plant is classified as \u201cofficial action required,\u201d a regulatory term meaning the site is in an unacceptable state of compliance, Novo said Monday.<\/p>\n Novo said in a statement that it\u2019s in contact with the FDA and its manufacturing customers about the new classification. Ensuring that the company meets manufacturing standards \u201cis a top priority, and we are enhancing our processes and procedures as part of our commitment to continuous improvement,\u201d it said.<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n