The FDA pointed to deficiencies in the cleaning and maintenance of equipment to prevent contamination of the drug product and also recommended the company review its quality control process, Emergent said.
Earlier in August, Emergent said the FDA last inspected its Camden facility in February and was awaiting the agency’s comments. The contract drug maker said it was meanwhile carrying out additional reviews with a third party to ensure “the delivery of medically necessary products”.
Emergent faced quality issues at another of its Baltimore plants that made Johnson & Johnson’s COVID-19 vaccine.
Manufacturing at the Emergent plant in Bayview was briefly halted last year after it was discovered that ingredients from AstraZeneca’s COVID-19 vaccine, which was also produced there at the time, had contaminated a batch of J&J vaccines.
J&J gave notice of termination of its vaccine manufacturing contract with the contract manufacturer in June.
Shares of Emergent were down 2.3% at $29.80 in aftermarket trading.