Tailor Made Compounding, LLC
FDA inspection history in Nicholasville, Kentucky, 2018 to 2022
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2020: one close-out letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–22Two Form 483s and one close-out letter, at Nicholasville, Kentucky.
- 2022The longest 483 on file: 13 observations over 17 pages at Nicholasville, Kentucky.
Cited most
Across all Tailor Made Compounding observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.28Personnel responsibilities2
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.111Time limitations on production1
The complete Tailor Made Compounding file.
All 3 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
Nicholasville, Kentucky
Two Form 483s and one close-out letter · 2018 to 2022 · 25 observations
Latest: Form 483, Mar 14, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-14 | 483 Form 483 | Nicholasville, Kentucky | 13 | $99 |
| 2020-04-01 | Close-out Close-out letter | Nicholasville, Kentucky | — | $99 |
| 2018-10-24 | 483 Form 483 | Nicholasville, Kentucky | 12 | $99 |
Investigators on these documents
Lauren N. Howard (1)Lisa R. Hilliard (1)Logan T. Williams (1)Michael P. Sheehan (1)Nicholas L. Paulin (1)
FEI number 3012315020 · most recent document Mar 14, 2022
About Tailor Made Compounding, LLC
How many FDA Form 483s has Tailor Made Compounding, LLC received?
FDA Intel has 2 Form 483s on file for Tailor Made Compounding, LLC; the most recent is dated Mar 14, 2022.
When was Tailor Made Compounding, LLC last inspected by FDA?
The most recent FDA inspection document on file for Tailor Made Compounding, LLC is a Form 483 dated Mar 14, 2022, for the site in Nicholasville, Kentucky.
What did FDA cite at Tailor Made Compounding, LLC?
The regulations cited most in the observations on file for Tailor Made Compounding, LLC are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.28 (Personnel responsibilities), 2 times.