Peeling Paint, Unsanitary Practices Among Issues at US Plant Making J&J COVID-19 Vaccine: FDA

A U.S. plant that was making Johnson & Johnson’s COVID-19 vaccine must fix a long list of problems including peeling paint and unsanitary conditions and practices to resume operation, according to a highly critical report by the 💊Food and Drug Administration.

Experts said addressing the issues raised in the scathing FDA inspection report could take months.

Neither J&J nor the FDA has said when they expect vaccine production to resume at the Baltimore plant owned by Emergent Biosolutions Inc. Only one plant is currently producing the key drug substance used in J&J’s vaccine, the company told Reuters by email.

“It may take many months to make these changes,” said Prashant Yadav, a global healthcare supply-chain expert at the Center for Global Development. He described some of the issues raised by the FDA as “quite significant.”

J&J said it will exercise its oversight authority to ensure that all of the FDA observations are addressed promptly and comprehensively.

The 12-page report described dirty facilities and workers who carried trash close to manufacturing areas. Problems were not investigated, cleanups were superficial, and the facility was not large enough, it added, describing crowded rooms.

“Paint flecks were observed on the floor all along the sides of these walls,” on corridors surrounding the manufacturing room, it said in one section, adding that there was “brown residue” on the wall and “black residue” on the floor in one plant room.

The healthcare company has drawn scrutiny for months over its halting process to scale up production of the one-shot vaccine that is easier to handle and use than other authorized vaccines.

Its use in the United States has been paused since last week as health officials study a possible link to a very rare but serious blood clot condition.