Wickliffe Pharmaceutical, Inc.
FDA inspection history across 3 sites, 2014 to 2024
- 3
- Form 483s
- 2
- Responses
- 1
- Untitled letter
- 1
- Close-out
Every document, by year
- Response
- Untitled letter
- Form 483
- Close-out
- Warning letter
2014: one warning letter and one Form 483; 2016: one close-out letter and one Form 483; 2023: one 483 response and one Form 483; 2024: one untitled letter response and one untitled letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Two Form 483s, one warning letter and one close-out letter, at Lexington, Kentucky and Lexin g to n, Kentucky.
- 2023–24One 483 response, one Form 483, one untitled letter response and one untitled letter, at Kentucky and Lexington, Kentucky.
- 2023The longest 483 on file: 7 observations over 8 pages at Lexington, Kentucky.
Cited most
Across all Wickliffe Pharmaceutical observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.115(a)Reprocessing1
- 21 CFR 211.150(b)Distribution procedures1
- 21 CFR 211.165Testing and release for distribution1
The complete Wickliffe Pharmaceutical file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Lexington, Kentucky
Two Form 483s, one untitled letter response, one close-out letter and one warning letter · 2014 to 2024 · 9 observations
Latest: Response, Jul 23, 2024 →Kentucky
One untitled letter and one 483 response · 2023 to 2024
Latest: Untitled letter, Jun 10, 2024 →Lexin g to n, Kentucky
One Form 483 · 2016 · 2 observations
Latest: Form 483, Apr 7, 2016 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-23 | Response Untitled letter response | Lexington, Kentucky | — | $199 |
| 2024-06-10 | Untitled letter Untitled letter | Kentucky | — | $99 |
| 2023-10-05 | Response 483 response | Kentucky | — | $199 |
| 2023-09-15 | 483 Form 483 | Lexington, Kentucky | 7 | $99 |
| 2016-08-12 | Close-out Close-out letter | Lexington, Kentucky | — | $99 |
| 2016-04-07 | 483 Form 483 | Lexin g to n, Kentucky | 2 | $99 |
| 2014-08-14 | Warning letter Warning letter | Lexington, Kentucky | — | $99 |
| 2014-05-22 | 483 Form 483 | Lexington, Kentucky | 2 | $99 |
Investigators on these documents
Kathleen Dt Culver (1)Lauren N. Howard (1)Logan T. Williams (1)Michael P. Sheehan (1)Stephanie M. Mongeluzzi (1)
FEI number 3002992930 · most recent document Jul 23, 2024
About Wickliffe Pharmaceutical, Inc.
How many FDA Form 483s has Wickliffe Pharmaceutical, Inc. received?
FDA Intel has 3 Form 483s on file for Wickliffe Pharmaceutical, Inc.; the most recent is dated Sep 15, 2023.
When was Wickliffe Pharmaceutical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Wickliffe Pharmaceutical, Inc. is a Form 483 dated Sep 15, 2023, for the site in Lexington, Kentucky.
What did FDA cite at Wickliffe Pharmaceutical, Inc.?
The regulations cited most in the observations on file for Wickliffe Pharmaceutical, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.115(a) (Reprocessing), 1 time.
Has Wickliffe Pharmaceutical, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Wickliffe Pharmaceutical, Inc.; the most recent is dated Aug 14, 2014.
Has Wickliffe Pharmaceutical, Inc. received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Wickliffe Pharmaceutical, Inc.; the most recent is dated Jun 10, 2024. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.