Infusion Options, Inc.
Form 483 issued June 25, 2020 · Brooklyn, New York
- Inspection
- Jun 25, 2020
- Investigators
- Jose O. Hernandez· Kevin J. Flessa
- Observations
- 17
- Pages
- 10
- FEI number
- 3008231170
In short: On June 25, 2020, FDA issued a Form 483 with 17 observations to Infusion Options, Inc. in Brooklyn, New York (FEI 3008231170) after an inspection that ran Jun 25, 2020. The investigators were Jose O. Hernandez and Kevin J. Flessa. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Dmg products are not stored under appropriate conditions of temperature and humidity so that their identity…
- 02
Procedures designed to prevent microbiological contamination of diug products purporting to be…
- 03
Unauthorized personnel have access to enter areas of the buildings and facilities designated…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) 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 17 observations on this Form 483, mostly about production, laboratory controls and 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 Infusion Options, Inc.?
Jose O. Hernandez and Kevin J. Flessa are named on this Form 483, for the inspection of Jun 25, 2020. Each investigator has a profile showing what they cite most.
When was Infusion Options, Inc. inspected by FDA?
The inspection ran Jun 25, 2020, and the Form 483 is dated June 25, 2020.
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.