Option Care Enterprises Inc. dba Option Care
Form 483 issued February 8, 2018 · WoodDale, Illinois
- Inspection
- Feb 8, 2018
- Investigator
- Brian D. Nicholson
- Observations
- 4
- Pages
- 2
- FEI number
- 3012188090
In short: On February 8, 2018, FDA issued a Form 483 with 4 observations to Option Care Enterprises Inc. dba Option Care in WoodDale, Illinois (FEI 3012188090) after an inspection that ran Feb 8, 2018. The investigator was Brian D. Nicholson. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Poor aseptic practices were…
- 02
Disinfecting agents, cleaning pads, and cleaning wipes used for sterile drug production were not always sterile…
- 03
Your facility design allowed the influx of poor quality air into…
- 04
Media fills were not performed under the most…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmOption Care Enterprises Inc. dba Option Care history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Option Care Enterprises Inc. dba Option Care?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Option Care Enterprises Inc. dba Option Care?
Brian D. Nicholson is named on this Form 483, for the inspection of Feb 8, 2018. Each investigator has a profile showing what they cite most.
When was Option Care Enterprises Inc. dba Option Care inspected by FDA?
The inspection ran Feb 8, 2018, and the Form 483 is dated February 8, 2018.
How do I get the full Form 483 for Option Care Enterprises Inc. dba Option Care?
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.