# FDA 483 - sentara enterprises  - July 14, 2023

Source: https://www.globalkeysolutions.net/records/483/sentara-enterprises/8252ad91-93fa-4fbb-88e2-fef4ad75528a

> FDA 483 for sentara enterprises  on July 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: sentara enterprises 
- Inspection Date: 2023-07-14
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) in Charlottesville, VA, identified five observations related to the production of sterile drug products. The findings indicate significant concerns regarding aseptic processing techniques, environmental control, and validation practices. Issues included improper aseptic manipulations, inadequate disinfection, insufficient media fill simulations, and poorly performed smoke studies.

## Related Documents

- [STATE_REFERRAL_LETTER - 2023-07-06](https://www.globalkeysolutions.net/records/state_referral_letter/sentara-enterprises/25f54371-d080-4fa1-8ef1-bd26e1c13e02)
- [483 - 2023-07-14](https://www.globalkeysolutions.net/records/483/sentara-enterprises/6849247f-8972-4a83-a9ac-4375f358044e)

## Related Officers

- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)
- [ Drug Investigator](https://www.globalkeysolutions.net/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.globalkeysolutions.net/companies/sentara-enterprises/199189b9-3919-4f80-a3ad-41b978ed662f

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