New Vitalis Pharmacy LLC
Form 483 issued September 7, 2018 · Louisville, Kentucky
- Inspection
- Aug 27 – Sep 7, 2018
- Investigator
- Bei Y. He
- Observations
- 3
- Pages
- 3
- FEI number
- 3014391500
In short: On September 7, 2018, FDA issued a Form 483 with 3 observations to New Vitalis Pharmacy LLC in Louisville, Kentucky (FEI 3014391500) after an inspection that ran Aug 27 – Sep 7, 2018. The investigator was Bei Y. He. Most observations concern materials and laboratory controls.
At a glance
Materials and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm released drug product in which the strength differs from, or its purity or quality…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Non-sterile, low-shedding wipes are used to cleaned…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmNew Vitalis Pharmacy LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New Vitalis Pharmacy LLC?
FDA listed 3 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected New Vitalis Pharmacy LLC?
Bei Y. He is named on this Form 483, for the inspection of Aug 27 – Sep 7, 2018. Each investigator has a profile showing what they cite most.
When was New Vitalis Pharmacy LLC inspected by FDA?
The inspection ran Aug 27 – Sep 7, 2018, and the Form 483 is dated September 7, 2018.
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.