'Based on the FDA's findings, I would be concerned about the sterility of the products made at this site,' said Susan Bain, an assistant professor of regulatory and quality sciences at the University of Southern California and former FDA inspector. Four regulatory experts and two former FDA inspectors who reviewed the documents told Reuters the findings raised concerns about the safety of all manufacturing being done at the factory, including for Wegovy. The FDA reports do not say how many filling lines were inspected or what drugs were being manufactured on the lines examined. Inspectors on both visits found Catalent staff were not performing required safety controls, with breaches including failing to regularly check that equipment was not contaminated with microbes. The August 2022 inspection found new problems with air quality in sterile areas had cropped up since the first visit, according to the FDA Establishment Inspection Reports written after each visit. 'Standard operating procedures are not followed or are deficient,' the report following the first inspection said.

Inspectors examining historical operational data found the system on one filling line at the plant had failed repeatedly between 20, leading to sterility being 'compromised' in the area where drug products were being manufactured, the FDA documents say. The most serious findings unearthed by the FDA during its October 2021 visit involved air-filtration systems needed to maintain sterile conditions.

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