New Vitalis Pharmacy LLC
Form 483 issued July 5, 2023 · Louisville, Kentucky
- Inspection
- Jun 12 – Jul 5, 2023
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 11
- Pages
- 8
- FEI number
- 3014391500
In short: On July 5, 2023, FDA issued a Form 483 with 11 observations to New Vitalis Pharmacy LLC in Louisville, Kentucky (FEI 3014391500) after an inspection that ran Jun 12 – Jul 5, 2023. The investigator was Ucheabuchi C. Chudi-Nwankwor.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Failure to conduct post-use filter-integrity testing on filters used…
- 02FDCA 501(a)(2)(A)
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
- 03FDCA 501(a)(2)(A)
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5…
- 04FDCA 501(a)(2)(A)
Use of a sporicidal agent in the facility's ISO 5 areas and…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmNew Vitalis Pharmacy LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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Questions about this 483
What did FDA find at New Vitalis Pharmacy LLC?
FDA listed 11 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected New Vitalis Pharmacy LLC?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Jun 12 – Jul 5, 2023. Each investigator has a profile showing what they cite most.
When was New Vitalis Pharmacy LLC inspected by FDA?
The inspection ran Jun 12 – Jul 5, 2023, and the Form 483 is dated July 5, 2023.
How do I get the full Form 483 for New Vitalis Pharmacy LLC?
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.