'U.S. FDA Finds Control Lapses At Moderna Manufacturing Plant' - Reuters News
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The U.S. FDA found quality control lapses at Moderna's main manufacturing plant in Norwood, Massachusetts during a September inspection. Issues included the use of equipment that failed cleaning verification tests to produce COVID-19 vaccine drug substance. Moderna released eight batches of this substance, but it's unclear if they reached the public. The FDA's report also noted the use of expired materials and potential contamination risks. Moderna has responded by updating procedures and maintains that its products are safe and meet regulatory requirements. There have been no recalls or reported harm from these lapses, and Moderna is expanding its in-house manufacturing capabilities.

December 15, 2023 | 8:54 pm
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FDA inspection found quality control issues at Moderna's manufacturing plant, including lapses with equipment used for COVID-19 vaccine production. Moderna has taken corrective actions and states that its vaccines are safe and effective.
The FDA's findings could potentially impact Moderna's reputation and investor confidence, leading to a short-term negative impact on the stock price. However, the company's proactive response and lack of recalls or reported harm may mitigate the severity of the impact.
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