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# FDA Details Contamination Findings at Emergent Plant
- URL: https://www.fdaweb.com/fda-details-contamination-findings-at-emergent-plant/
- Published: 2021-06-14T12:00:00.000Z
- Updated: 2026-09-14T17:03:15.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149528

FDA has [released more information](https://www.fda.gov/media/150081/download?ref=fdaweb.com) concerning Janssen’s Covid-19 contaminated vaccine substance made at Emergent BioSolutions’ troubled contract manufacturing facility in Baltimore. Earlier this year, Emergent was found to have significant GMP deviations that led to an agreement to shut down operations until corrections are implemented ([see earlier story](https://www.fdaweb.com/j-j-vaccine-maker-halts-production/)).  

According to the agency, Janssen 3/26 reported detecting an AstraZeneca vaccine virus, which was made at the same plant, in a Janssen Covid-19 vaccine drug substance batch. The root cause, FDA says, was likely bioreactor media prepared for use in the cell expansion process that had been contaminated in the common weigh and dispense area through contact with the waste path for materials from the AstraZeneca manufacturing area. The contamination triggered an FDA “for cause” inspection and a Form FDA-483 was issued ([see story](https://www.fdaweb.com/emergent-bio-covid-vaccine-9-item-fda-form-483/)).

Based on FDA findings, the agency provided its rationale for determining which batches were acceptable for use and which were were not, which it announced 6/11 ([see earlier story](https://www.fdaweb.com/fda-oks-2-covid-19-batches-made-at-troubled-facility/)). Additionally, FDA says it added a condition on using or exporting the two batches (about 10 million doses) — “Janssen and Emergent must agree that FDA may share all relevant information about the manufacture of the batches with the regulatory authorities of the countries in which the vaccine may be used. This will provide the regulatory authorities in destination countries with the relevant information necessary for those authorities who may wish to make their own judgment on the suitability of these two batches for use in their countries.”