Catalent, one of the largest contract manufacturers in the pharmaceutical industry, was cited by the U.S. Food and Drug Administration for a series of quality control failures at a facility in Bloomington, Ind., the same plant where the company helps produce two Covid-19 vaccines. The issues prompted the agency to delay distribution of Moderna booster shots, although their release has now reportedly been authorized.
Following a recent month-long inspection, the agency scolded Catalent for various problems, such as failing to investigate unexplained discrepancies in batches of products and to ensure that product sampling and testing met quality control criteria. The company also failed to investigate complaints from customers, including 179 instances in which particles were found in vials over the past year.
Among the other manufacturing issues cited by the FDA: Catalent relied on certain equipment that was not designed for how it was being used; the company failed to develop procedures for preventing microbiological contamination of products that are supposed to be sterile; and routine checks on equipment were not conducted.
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