Infusion Options, Inc.
Form 483 issued April 23, 2014 · Brooklyn, New York
- Inspection
- Apr 9 – Apr 23, 2014
- Investigators
- D. Jenny Xiradakis· James A. Liubicich
- Observations
- 13
- Pages
- 9
- FEI number
- 3008231170
In short: On April 23, 2014, FDA issued a Form 483 with 13 observations to Infusion Options, Inc. in Brooklyn, New York (FEI 3008231170) after an inspection that ran Apr 9 – Apr 23, 2014. The investigators were D. Jenny Xiradakis and James A. Liubicich. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (4×)
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 systems for maintaining any equipment used to…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
D. Jenny Xiradakis
1 document · 2014
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmInfusion Options, Inc. history
All 5 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 Infusion Options, Inc.?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, production 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 Infusion Options, Inc.?
D. Jenny Xiradakis and James A. Liubicich are named on this Form 483, for the inspection of Apr 9 – Apr 23, 2014. Each investigator has a profile showing what they cite most.
When was Infusion Options, Inc. inspected by FDA?
The inspection ran Apr 9 – Apr 23, 2014, and the Form 483 is dated April 23, 2014.
How do I get the full Form 483 for Infusion Options, 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.