Brown's Compounding Center, Inc.
FDA inspection history across 3 sites, 2014 to 2016
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Warning letter
- Form 483
2014: one Form 483; 2015: one Form 483; 2016: one close-out letter and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Two Form 483s, one close-out letter and one warning letter, at Englewood, Colorado; Denver, Colorado and Parker, Colorado.
- 2015The longest 483 on file: 6 observations over 3 pages at Englewood, Colorado.
Cited most
Across all Brown's Compounding Center observations on file
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.166(a)(3)Stability testing2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(a)Testing and release for distribution1
The complete Brown's Compounding Center 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
Englewood, Colorado
Two Form 483s · 2014 to 2015 · 11 observations
Latest: Form 483, Apr 27, 2015 →Denver, Colorado
One close-out letter · 2016
Latest: Close-out, Nov 14, 2016 →Parker, Colorado
One warning letter · 2016
Latest: Warning letter, Aug 17, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-11-14 | Close-out Close-out letter | Denver, Colorado | — | $99 |
| 2016-08-17 | Warning letter Warning letter | Parker, Colorado | — | $99 |
| 2015-04-27 | 483 Form 483 | Englewood, Colorado | 6 | $99 |
| 2014-08-11 | 483 Form 483 | Englewood, Colorado | 5 | $99 |
Investigators on these documents
Erika V. Butler (1)Isabel Y. Espinosa (1)Michael A. Charles (1)Tomika L. Bivens (1)
FEI number 3010894019 · most recent document Nov 14, 2016
About Brown's Compounding Center, Inc.
How many FDA Form 483s has Brown's Compounding Center, Inc. received?
FDA Intel has 2 Form 483s on file for Brown's Compounding Center, Inc.; the most recent is dated Apr 27, 2015.
When was Brown's Compounding Center, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Brown's Compounding Center, Inc. is a Form 483 dated Apr 27, 2015, for the site in Englewood, Colorado.
What did FDA cite at Brown's Compounding Center, Inc.?
The regulations cited most in the observations on file for Brown's Compounding Center, Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 2 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.166(a)(3) (Stability testing), 2 times.
Has Brown's Compounding Center, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Brown's Compounding Center, Inc.; the most recent is dated Aug 17, 2016.