New Vitalis Pharmacy LLC
Form 483 issued August 27, 2021 · Louisville, Kentucky
- Inspection
- Aug 23 – Aug 27, 2021
- Investigators
- Carl A. Huffman· Lauren N. Howard
- Observations
- 7
- Pages
- 5
- FEI number
- 3014391500
In short: On August 27, 2021, FDA issued a Form 483 with 7 observations to New Vitalis Pharmacy LLC in Louisville, Kentucky (FEI 3014391500) after an inspection that ran Aug 23 – Aug 27, 2021. The investigators were Carl A. Huffman and Lauren N. Howard.
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
Vermin was observed in an area immediately adjacent…
- 02FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 03FDCA 501(a)(2)(A)
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around…
- 04FDCA 501(a)(2)(A)
HEPA filters were not sealed around each perimeter…
This inspection in context
Carl A. Huffman
11 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
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 7 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected New Vitalis Pharmacy LLC?
Carl A. Huffman and Lauren N. Howard are named on this Form 483, for the inspection of Aug 23 – Aug 27, 2021. Each investigator has a profile showing what they cite most.
When was New Vitalis Pharmacy LLC inspected by FDA?
The inspection ran Aug 23 – Aug 27, 2021, and the Form 483 is dated August 27, 2021.
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.