Biologics

Catalent Issued 2 FDA Form 483s

FDA has issued two separate Form 483 inspection reports citing a range of quality and compliance deficiencies at Catalent Maryland, Inc., highlighting ongoing challenges in the company’s contract biologics and gene therapy manufacturing. The inspections, conducted in April at the company’s Baltimore and Harmans, MD, facilities, identified multiple lapses affecting sterility, equipment qualification, environmental monitoring, personnel training, and recordkeeping. The inspection reports were posted this week by CBER.

At the Baltimore site, which produces the gene therapy product delandistrogene moxeparvovec-rokl (Sarepta’s Elevidys), FDA inspectors noted that operators did not follow established aseptic procedures during filling operations. Specific observations included failure to sanitize gloves frequently, rapid and careless movements within restricted aseptic areas, and repeated handling of vials in ways that could compromise sterility. Inspectors also cited maintenance issues, including flooring in personnel areas that posed contamination risks, with work orders issued only after the inspection.

The second inspection, at Catalent’s Harmans site, focused on gene therapy manufacturing and uncovered further compliance concerns. FDA investigators noted that identity testing was not performed on incoming drug substances, sterility release procedures lacked defined testing timeframes, and critical manufacturing equipment, such as peristaltic pumps, had not been routinely calibrated or requalified. Environmental monitoring programs were found to be deficient, and procedures for personnel qualification and operator training did not adequately reflect actual production conditions. In addition, the company was found to have lapses in following written procedures for document control and record retention, including missing logs for executed batch records.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome