Thread by @megtirrell

FDA says it concludes inspection of Emergent plant, issues 483 letter. Production of J&J vaccine remains stopped until issues are remediated. 483 letter here: fda.gov/media/147762/d…

FDA observations re Emergent plant:

1: Failure to conduct thorough investigations into unexplained discrepancies.

Specifically, cross-contamination of two viral vaccines. FDA: “there is no assurance that other batches have not been subject to cross-contamination.”

Note- FDA cites “cross-contamination of client [redacted] viral vaccine drug substance batch... with the virus from client [redacted].”

Emergent’s CEO April 1: “It wasn’t the case where an ingredient from one vaccine contaminated or impacted the other.”

cnbc.com/video/2021/04/…

Observation 2: The building used for manufacture of the client [redacted] viral vaccine drug substance and client [redacted] viral vaccine drug substance is not maintained in a clean and sanitary condition.

Waste not decontaminated, peeling paint on floors & walls, FDA notes

Observation 3: The building used for the manufacture of the client [redacted] viral vaccine drug substance and client [redacted] viral vaccine drug substance is not of suitable size, design, and location to facilitate cleaning, maintenance and proper operations

Observation 4: Written production and process control procedures to prevent cross-contamination are not followed in the execution of production and process control functions and are not documented at the time of performance.

Observation 4 includes reference to a manufacturing worker who didn’t de-gown and shower while moving between different manufacturing areas of the Emergent plant - the reported (by NYT) way contamination of J&J vaccine happened

Observation 5: The components, product containers and/or closures were not handled and/or stored in a manner to prevent contamination.

Security camera footage revealed employees carrying unsealed bags of medical waste, which contacted containers of staged manufacturing materials

Observation 6: Written procedures designed to assure that the drug substances manufactured in the facility have the identity, strength, quality, and purity they purport or are represented to are inadequate.

Mainly, issues with decontamination:

Observation 7: Employees were not trained in the particular operation that they performed and/or in CGMPs (Current Good Manufacturing Practices) related to their job function.

Review of security cam footage observed employees moving btw spaces & moving waste w/o proper controls

Observation 8: Equipment used is not of adequate size to facilitate operations for its intended use or for cleaning and maintenance.

Observation 9: Equipment and/or utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug substance.

In statement on FDA’s inspection, Emergent says “the issuance of findings by the FDA is normal following a facility inspection,” & that issues identified “are correctable and we will take swift action to remedy them.” (H/t @strickdc)

J&J says in statement it “will exercise its oversight authority to ensure that all of FDA’s observations are addressed promptly and comprehensively” at Emergent plant, and notes global vaccine supply network it’s establishing “to meet its commitments.”

FDA’s @DrWoodcockFDA & Peter Marks add in statement that Emergent’s production of J&J vaccine will be paused, no product released until issues at plant are resolved.

This is the only U.S. plant making J&J #covid19 vaccine drug substance at the moment, until Merck comes on board.