Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)
Form 483 issued July 14, 2023 · Charlottesville, Virginia
- Inspection
- Jul 6 – Jul 14, 2023
- Investigators
- Sena G. Dissmeyer· Tekalign Wondimu
- Observations
- 5
- Pages
- 4
- FEI number
- 3025984445
In short: On July 14, 2023, FDA issued a Form 483 with 5 observations to Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) in Charlottesville, Virginia (FEI 3025984445) after an inspection that ran Jul 6 – Jul 14, 2023. The investigators were Sena G. Dissmeyer and Tekalign Wondimu.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5…
- 02FDCA 501(a)(2)(A)
Personnel performed aseptic manipulations with…
- 03FDCA 501(a)(2)(A)
Lack of disinfection of supplies at each transition from areas of lower quality air to areas…
- 04FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
This inspection in context
Sena G. Dissmeyer
20 documents · 2017–2023
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Maryland.
The firmSentara Enterprises dba Sentara Infusion Services (Blue Ridge) history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)?
FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)?
Sena G. Dissmeyer and Tekalign Wondimu are named on this Form 483, for the inspection of Jul 6 – Jul 14, 2023. Each investigator has a profile showing what they cite most.
When was Sentara Enterprises dba Sentara Infusion Services (Blue Ridge) inspected by FDA?
The inspection ran Jul 6 – Jul 14, 2023, and the Form 483 is dated July 14, 2023.
How do I get the full Form 483 for Sentara Enterprises dba Sentara Infusion Services (Blue Ridge)?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.