# FDA 483 - Emergent Biosolutions LLC - August 16, 2023

Source: https://www.globalkeysolutions.net/records/483/emergent-biosolutions-llc/d7d52447-f29c-4a6b-a2c9-99be41ce1ae0

> FDA 483 for Emergent Biosolutions LLC on August 16, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Emergent Biosolutions LLC
- Inspection Date: 2023-08-16
- Product Type: biologics
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: An FDA inspection of Emergent Biosolutions LLC in Canton, MA, a licensed biological drug substance manufacturer, identified two significant issues. The firm failed to make records, specifically security camera footage used in deviation investigations for ACAM2000 bulk drug substance manufacturing, readily available for inspection. Additionally, aseptic process simulation studies did not accurately reflect routine aseptic manufacturing operations, particularly concerning the sterilization process for the ACAM2000 P10 viral process.

## Related Documents

- [483 - 2017-12-21](https://www.globalkeysolutions.net/records/483/emergent-biosolutions-llc/878d4eff-86a9-4383-84fd-d7d5a3ccde2f)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)
- [Lewis K. Antwi](https://www.globalkeysolutions.net/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)
- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/emergent-biosolutions-llc/a4e71e63-5d44-4dd7-a589-a755c72b0637

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7