Firm Record

Emergent Manufacturing Operations Baltimore LLC findings history

25 findings from 4 inspection documents published by regulators. Each row below says what its date means.

EMA (Europe)US FDAHealth Canada 2021-04-23 ~ 2022-04-01 4 documents 25 findings

Areas cited

Other quality systemEquipment and facilityLaboratory and QC controlsMaterial and supplier controlComputer system validationProcess validationTraining and personnelRegulatory reporting and change controlComplaint and recall handlingDeviation, CAPA, and investigationQuality unit oversight

Published inspection documents

2022-04-01 EMA (Europe) 1 findingsComplaint and recall handling The site fails to demonstrate full control of the manufacturing process of Janssen’s viral vector drug substance with repeated contamination issues as well as a history of cross contamination with another viral vector vaccine drug substance. After 14 batches manufactured (7 of which were terminated), the site has failed to provide 3 successful consecutive PPQ batches. In light of the recent contamination issues (notified on the 7th of February and updated on the 18th of March 2022) and the unsuccessful PPQ runs, it is concluded that the site has failed to demonstrate consistent production of viral vector vaccine drug substance in accordance to the EU GMP requirements and that contamination issues are still present and are not under control which presents a risk to the quality of the vaccines and public health. Action taken/proposed by the NCA: Recall of batches already released Consideration for recall of vaccines produced with drug substance originating from the Emergent facility Prohibition of supply No further supplies of Janssen’s COVID vaccine’s drug substance should be allowed in the Union 2021-10-25 Health Canada 11 findingsOther quality system · Laboratory and QC controls · Equipment and facility · Computer system validation · Deviation, CAPA, and investigation · Regulatory reporting and change control The working spaces were inadequate. 2021-05-13 US FDA 8 findingsEquipment and facility · Material and supplier control · Process validation · Other quality system Equipment used is not of adequate size to facilitate operations for its intended use or for cleaning and maintenance. 2021-04-23 US FDA 5 findingsComputer system validation · Quality unit oversight · Material and supplier control · Training and personnel · Laboratory and QC controls Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel Specifically, A.

About this page

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of Emergent Manufacturing Operations Baltimore LLC — including inspection classifications Browse by document Go to Findings search