New Vitalis Pharmacy LLC
FDA inspection history in Louisville, Kentucky, 2018 to 2023
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2018: one Form 483; 2021: one Form 483; 2022: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Louisville, Kentucky.
- 2021–23Two Form 483s and one warning letter, at Louisville, Kentucky.
- 2023The longest 483 on file: 11 observations over 8 pages at Louisville, Kentucky.
Cited most
Across all New Vitalis Pharmacy observations on file
- FDCA 501(a)(2)(A)Insanitary conditions18
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete New Vitalis Pharmacy file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Louisville, Kentucky
Three Form 483s and one warning letter · 2018 to 2023 · 21 observations
Latest: Form 483, Jul 5, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-07-05 | 483 Form 483 | Louisville, Kentucky | 11 | $99 |
| 2022-05-18 | Warning letter Warning letter | Louisville, Kentucky | — | $99 |
| 2021-08-27 | 483 Form 483 | Louisville, Kentucky | 7 | $99 |
| 2018-09-07 | 483 Form 483 | Louisville, Kentucky | 3 | $99 |
Investigators on these documents
Bei Y. He (1)Carl A. Huffman (1)Lauren N. Howard (1)Ucheabuchi C. Chudi-Nwankwor (1)
FEI number 3014391500 · most recent document Jul 5, 2023
About New Vitalis Pharmacy LLC
How many FDA Form 483s has New Vitalis Pharmacy LLC received?
FDA Intel has 3 Form 483s on file for New Vitalis Pharmacy LLC; the most recent is dated Jul 5, 2023.
When was New Vitalis Pharmacy LLC last inspected by FDA?
The most recent FDA inspection document on file for New Vitalis Pharmacy LLC is a Form 483 dated Jul 5, 2023, for the site in Louisville, Kentucky.
What did FDA cite at New Vitalis Pharmacy LLC?
The regulations cited most in the observations on file for New Vitalis Pharmacy LLC are FDCA 501(a)(2)(A) (Insanitary conditions), 18 times; 21 CFR 211.165 (Testing and release for distribution), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.
Has New Vitalis Pharmacy LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for New Vitalis Pharmacy LLC; the most recent is dated May 18, 2022.