Healix Infusion Therapy, Inc.
Form 483 issued September 14, 2016 · Sugar Land, Texas
- Inspection
- Sep 1 – Sep 14, 2016
- Investigator
- Stephen D. Brown
- Observations
- 1
- Pages
- 1
- FEI number
- 3010166765
In short: On September 14, 2016, FDA issued a Form 483 with 1 observation to Healix Infusion Therapy, Inc. in Sugar Land, Texas (FEI 3010166765) after an inspection that ran Sep 1 – Sep 14, 2016. The investigator was Stephen D. Brown. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and…
This inspection in context
Stephen D. Brown
42 documents · 2006–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmHealix Infusion Therapy, Inc. history
All 2 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 Healix Infusion Therapy, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Healix Infusion Therapy, Inc.?
Stephen D. Brown is named on this Form 483, for the inspection of Sep 1 – Sep 14, 2016. Each investigator has a profile showing what they cite most.
When was Healix Infusion Therapy, Inc. inspected by FDA?
The inspection ran Sep 1 – Sep 14, 2016, and the Form 483 is dated September 14, 2016.
How do I get the full Form 483 for Healix Infusion Therapy, Inc.?
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.