Janssen Vaccines Corp., A Johnson & Johnson Company

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

You failed to conduct adequate investigations of recurring complaints received between November 13, 2023, and November 8, 2024, for **(b)(4)** stopper **(b)(4)** associated with **(b)(4)** injection, **(b)(4)** mg/**(b)(4)** mL. Several complaints included reports of stopper **(b)(4)** events associated with two or more vials, including one complaint that reported stopper **(b)(4)** in four vials from the same batch.