Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy
FDA inspection history in Wheaton, Illinois, 2015 to 2017
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter and one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Three Form 483s and one warning letter, at Wheaton, Illinois.
- 2016The longest 483 on file: 18 observations over 18 pages at Wheaton, Illinois.
Cited most
Across all Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
The complete Wellcare Rx Investments LLC dba Denson's Specialty 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
Wheaton, Illinois
Three Form 483s and one warning letter · 2015 to 2017 · 37 observations
Latest: Form 483, Nov 13, 2017 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-11-13 | 483 Form 483 | Wheaton, Illinois | 1 | $99 |
| 2016-09-30 | Warning letter Warning letter | Wheaton, Illinois | — | $99 |
| 2016-01-06 | 483 Form 483 | Wheaton, Illinois | 18 | $99 |
| 2015-11-19 | 483 Form 483 | Wheaton, Illinois | 18 | $99 |
Investigators on these documents
FEI number 3011707930 · most recent document Nov 13, 2017
About Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy
How many FDA Form 483s has Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy received?
FDA Intel has 3 Form 483s on file for Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy; the most recent is dated Nov 13, 2017.
When was Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy is a Form 483 dated Nov 13, 2017, for the site in Wheaton, Illinois.
What did FDA cite at Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy?
The regulations cited most in the observations on file for Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 3 times.
Has Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy; the most recent is dated Sep 30, 2016.