Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy
Form 483 issued November 19, 2015 · Wheaton, Illinois
- Inspection
- Sep 8, 2015
- Investigator
- Debra I. Love
- Observations
- 18
- Pages
- 16
- FEI number
- 3011707930
In short: On November 19, 2015, FDA issued a Form 483 with 18 observations to Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy in Wheaton, Illinois (FEI 3011707930) after an inspection that ran Sep 8, 2015. The investigator was Debra I. Love. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Packages cootaining sterile items necessary for production were opened outside ofthe laminar air flow hood exposing…
This inspection in context
Debra I. Love
13 documents · 2009–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmWellcare Rx Investments LLC dba Denson's Specialty Pharmacy history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy?
FDA listed 18 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy?
Debra I. Love is named on this Form 483, for the inspection of Sep 8, 2015. Each investigator has a profile showing what they cite most.
When was Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy inspected by FDA?
The inspection ran Sep 8, 2015, and the Form 483 is dated November 19, 2015.
How do I get the full Form 483 for Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.