Infusion Options, Inc.
Form 483 issued June 25, 2019 · Brooklyn, New York
- Inspection
- May 30 – Jun 25, 2019
- Investigator
- Jose O. Hernandez-Gumlan
- Observations
- 1
- Pages
- 1
- FEI number
- 3015452722
In short: On June 25, 2019, FDA issued a Form 483 with 1 observation to Infusion Options, Inc. in Brooklyn, New York (FEI 3015452722) after an inspection that ran May 30 – Jun 25, 2019. The investigator was Jose O. Hernandez-Gumlan. Most observations concern materials; the most-cited regulation is 21 CFR 211.142 (warehousing procedures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.142 (1×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity…
This inspection in context
Jose O. Hernandez-Gumlan
1 document · 2019
Cites 211.142 (warehousing procedures) more than any other section. Most of their documents are for sites in New York.
The firmInfusion Options, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.142
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infusion Options, Inc.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.142 (warehousing procedures). The opening words of each observation are shown on this page.
Who inspected Infusion Options, Inc.?
Jose O. Hernandez-Gumlan is named on this Form 483, for the inspection of May 30 – Jun 25, 2019. Each investigator has a profile showing what they cite most.
When was Infusion Options, Inc. inspected by FDA?
The inspection ran May 30 – Jun 25, 2019, and the Form 483 is dated June 25, 2019.
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.