# FDA 483 - InfuScience, Inc. dba Bioscrip Infusion Services - October 08, 2021

Source: https://www.keypedia.com/records/483/infuscience-inc-dba-bioscrip-infusion-services/3226c5db-63d0-459f-bb21-b832873bc71e

> FDA 483 for InfuScience, Inc. dba Bioscrip Infusion Services on October 08, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: InfuScience, Inc. dba Bioscrip Infusion Services
- Inspection Date: 2021-10-08
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of InfuScience, Inc. dba Bioscrip Infusion Services in Chantilly, VA, identified critical deficiencies in aseptic processing and environmental controls. Observations included visibly dirty equipment in ISO 5 areas, improper aseptic manipulations that blocked first-pass air, and inadequate certification of cleanroom conditions. The facility's media fills were also found to be insufficient in simulating actual production operations and lacked proper controls.

## Related Documents

- [483 - 2019-07-30](https://www.keypedia.com/records/483/infuscience-inc-dba-bioscrip-infusion-services/00812eb7-7d71-4037-ab90-f6c649b99091)
- [WARNING_LETTER - 2019-07-30](https://www.keypedia.com/records/warning_letter/infuscience-inc-dba-bioscrip-infusion-services/1223955e-05a5-422b-8154-7f361c9f9d2a)
- [483 - 2021-10-08](https://www.keypedia.com/records/483/infuscience-inc-dba-bioscrip-infusion-services/5a2d0887-0f36-40d2-a00c-df81356811b5)

## Related Officers

- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [Attorney](https://www.keypedia.com/people/marcia-d-fields/7dec60da-6a56-4709-b748-c3218da5c116)

Company: https://www.keypedia.com/companies/infuscience-inc-dba-bioscrip-infusion-services/6fb79324-4213-45fa-878b-073a1bccf737

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64