Infusion Options, Inc.
Form 483 issued June 1, 2017 · Brooklyn, New York
- Inspection
- May 15 – Jun 1, 2017
- Investigator
- Robert C. Horan
- Observations
- 7
- Pages
- 4
- FEI number
- 3008231170
In short: On June 1, 2017, FDA issued a Form 483 with 7 observations to Infusion Options, Inc. in Brooklyn, New York (FEI 3008231170) after an inspection that ran May 15 – Jun 1, 2017. The investigator was Robert C. Horan. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Robert C. Horan
13 documents · 1998–2018
Cites 211.192 (production record review) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Infusion Options, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Infusion Options, Inc.?
Robert C. Horan is named on this Form 483, for the inspection of May 15 – Jun 1, 2017. Each investigator has a profile showing what they cite most.
When was Infusion Options, Inc. inspected by FDA?
The inspection ran May 15 – Jun 1, 2017, and the Form 483 is dated June 1, 2017.
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.