Heartland Home Infusions, Inc., dba HHI Infusion Services
Form 483 issued July 27, 2017 · Burr Ridge, Illinois
- Inspection
- Jul 6 – Jul 27, 2017
- Investigator
- Christina A. Miller
- Observations
- 3
- Pages
- 2
- FEI number
- 3013442653
In short: On July 27, 2017, FDA issued a Form 483 with 3 observations to Heartland Home Infusions, Inc., dba HHI Infusion Services in Burr Ridge, Illinois (FEI 3013442653) after an inspection that ran Jul 6 – Jul 27, 2017. The investigator was Christina A. Miller. Most observations concern facilities & equipment and production.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Sporicidal agents are not used in your facility's cleanrooms…
- 02
Beta-lactam drugs were produced without providing adequate containment, segregation, and cleaning of work surfaces and…
- 03
Non-microbial contamination was observed…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmHeartland Home Infusions, Inc., dba HHI Infusion Services history
The site's inspection history, in date order.
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 Heartland Home Infusions, Inc., dba HHI Infusion Services?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Heartland Home Infusions, Inc., dba HHI Infusion Services?
Christina A. Miller is named on this Form 483, for the inspection of Jul 6 – Jul 27, 2017. Each investigator has a profile showing what they cite most.
When was Heartland Home Infusions, Inc., dba HHI Infusion Services inspected by FDA?
The inspection ran Jul 6 – Jul 27, 2017, and the Form 483 is dated July 27, 2017.
How do I get the full Form 483 for Heartland Home Infusions, Inc., dba HHI Infusion Services?
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.