US Compounding Inc.
FDA inspection history across 2 sites, 2014 to 2019
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one Form 483; 2016: one Form 483; 2017: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–19Four Form 483s and one warning letter, at Conway, Arkansas and Conway, Arizona.
- 2015The longest 483 on file: 11 observations over 11 pages at Conway, Arkansas.
Cited most
Across all US Compounding observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.166Stability testing2
- 21 CFR 211.192Production record review2
The complete US Compounding file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Conway, Arkansas
Three Form 483s and one warning letter · 2014 to 2017 · 25 observations
Latest: Warning letter, Oct 10, 2017 →Conway, Arizona
One Form 483 · 2019 · 10 observations
Latest: Form 483, Feb 7, 2019 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-07 | 483 Form 483 | Conway, Arizona | 10 | $99 |
| 2017-10-10 | Warning letter Warning letter | Conway, Arkansas | — | $99 |
| 2016-07-15 | 483 Form 483 | Conway, Arkansas | 6 | $99 |
| 2015-08-21 | 483 Form 483 | Conway, Arkansas | 11 | $99 |
| 2014-03-27 | 483 Form 483 | Conway, Arkansas | 8 | $99 |
Investigators on these documents
Massoud Motamed (2)Erika V. Butler (1)June P. Page (1)Kimberley A. Hoefeo (1)Lloyd D. Payne (1)Scott Ballard (1)
FEI number 3006031801 · most recent document Feb 7, 2019
About US Compounding Inc.
How many FDA Form 483s has US Compounding Inc. received?
FDA Intel has 4 Form 483s on file for US Compounding Inc.; the most recent is dated Feb 7, 2019.
When was US Compounding Inc. last inspected by FDA?
The most recent FDA inspection document on file for US Compounding Inc. is a Form 483 dated Feb 7, 2019, for the site in Conway, Arizona.
What did FDA cite at US Compounding Inc.?
The regulations cited most in the observations on file for US Compounding Inc. are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.165 (Testing and release for distribution), 3 times.
Has US Compounding Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for US Compounding Inc.; the most recent is dated Oct 10, 2017.