# FDA 483 - Sentara Infusion Services - December 16, 2022

Source: https://www.keypedia.com/records/483/sentara-infusion-services/4306220a-ac2a-40a2-bc96-81a198182ef1

> FDA 483 for Sentara Infusion Services on December 16, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sentara Infusion Services
- Inspection Date: 2022-12-16
- Product Type: Drugs
- Office Name: Baltimore District Office
- Summary: During an FDA inspection from December 5-16, 2022, Sentara Infusion Services, a producer of sterile drug products located at 535 Independence Pkwy Ste 300, Chesapeake, VA, received a Form 483 with ten observations.

Key violations include:
1.  **Non-sterile cleaning agents:** Disinfecting agents and wipes used in ISO 5 aseptic processing areas were not sterile. Non-sterile wipes were used as work surfaces and for cleaning. Disinfectant contact times were insufficient.
2.  **Inadequate microbial contamination response:** Actionable microbial contamination was consistently found in ISO 7 areas (adjacent to ISO 5 aseptic processing areas) since November 2020, including Penicillium sp., Exserhilum sp., Hormographiella sp., Cladosporium sp., Geotrichum sp., Coagulase (-) Staphylococcus sp., Bacillus sp., Trichoderma sp., and Aspergillus sp. Product evaluation and remedial actions were deemed inadequate.
3.  **Cross-contamination risk:** Inadequate cleaning of work surfaces after beta-lactam drug production was observed, with spillage not being deactivated or removed, posing a cross-contamination risk to subsequent non-beta-lactam products.
4.  **Personnel gowning deficiencies:** Technicians were observed with exposed wrists and exposed hair in ISO 5 classified laminar airflow hoods during sterile drug production.
5.  **

## Related Documents

- [483 - 2015-07-23](https://www.keypedia.com/records/483/sentara-infusion-services/0478b531-fb04-4648-8c20-73afd0a0f657)
- [483_RESPONSE - 2015-07-23](https://www.keypedia.com/records/483_response/sentara-infusion-services/b0494455-9d68-4099-bd6b-7bc57e1aaa4c)
- [483 - 2022-12-16](https://www.keypedia.com/records/483/sentara-infusion-services/b2b72b87-386a-414e-aa98-f8c8d65b2d85)

## Related Officers

- [Investigator](https://www.keypedia.com/people/karen-a-briggs/3e77d364-25ea-48c7-87f4-36f3e170bfb5)
- [Consumer Safety Officer](https://www.keypedia.com/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Sena G. Dissmeyer](https://www.keypedia.com/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.keypedia.com/companies/sentara-infusion-services/96cac868-e9c3-442c-883e-d92b5ac0fd49

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa