Catalent has recently been issued two Form 483s by the FDA concerning its gene therapy facilities located in Maryland, which are primarily involved in manufacturing products for Sarepta. These forms indicate that FDA inspectors identified significant deviations from current Good Manufacturing Practices (cGMP) during their inspections.
This development comes on the heels of a series of mass layoffs at the Maryland sites, raising concerns about the operational stability and regulatory compliance of Catalent’s gene therapy production. The issuance of Form 483s not only highlights potential quality assurance issues but may also impact Catalent’s reputation and business relationships within the pharmaceutical industry.
As regulatory scrutiny intensifies, the implications for Catalent could be profound, potentially affecting its ability to fulfill contracts and maintain market position in the rapidly evolving gene therapy sector. Stakeholders in regulatory affairs, quality assurance, and supply chain management will need to closely monitor the situation as it unfolds.
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