Healix Infusion Therapy, Inc.
Form 483 issued May 16, 2014 · Sugar Land, Texas
- Inspection
- May 12 – May 16, 2014
- Investigators
- Darla J. Christopher· Dorcas A. Taylor· Margaret M. Annes
- Observations
- 3
- Pages
- 2
- FEI number
- 3010166765
In short: On May 16, 2014, FDA issued a Form 483 with 3 observations to Healix Infusion Therapy, Inc. in Sugar Land, Texas (FEI 3010166765) after an inspection that ran May 12 – May 16, 2014. The investigators were Darla J. Christopher, Dorcas A. Taylor and Margaret M. Annes. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
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…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
This inspection in context
Darla J. Christopher
10 documents · 2010–2020
Cites 211.42 (design and construction features) 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 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Healix Infusion Therapy, Inc.?
Darla J. Christopher, Dorcas A. Taylor and Margaret M. Annes are named on this Form 483, for the inspection of May 12 – May 16, 2014. Each investigator has a profile showing what they cite most.
When was Healix Infusion Therapy, Inc. inspected by FDA?
The inspection ran May 12 – May 16, 2014, and the Form 483 is dated May 16, 2014.
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.