Wellcare Rx Investments LLC dba Denson's Specialty Pharmacy
Form 483 issued January 6, 2016 · Wheaton, Illinois
- Inspection
- Aug 12, 2015 – Jan 6, 2016
- Investigator
- Debra I. Love
- Observations
- 18
- Pages
- 18
- FEI number
- 3011707930
In short: On January 6, 2016, 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 Aug 12, 2015 – Jan 6, 2016. The investigator was Debra I. Love. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 12 of 18 observations.
Most cited: 21 CFR 211.42 (4×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
During a field examination of drug products at your facility…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Aseptic processing areas are deficient regarding the system…
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 211.42
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, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). 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 Aug 12, 2015 – Jan 6, 2016. 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 Aug 12, 2015 – Jan 6, 2016, and the Form 483 is dated January 6, 2016.
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.