Option Care Enterprises Inc. dba Option Care
Form 483 issued September 21, 2016 · Wood Dale, Illinois
- Inspection
- Sep 1 – Sep 21, 2016
- Investigator
- Christopher D. Leach
- Observations
- 1
- Pages
- 2
- FEI number
- 3012188090
In short: On September 21, 2016, FDA issued a Form 483 with 1 observation to Option Care Enterprises Inc. dba Option Care in Wood Dale, Illinois (FEI 3012188090) after an inspection that ran Sep 1 – Sep 21, 2016. The investigator was Christopher D. Leach. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.28 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A finished drug product has been prepared, packed, or held under insanitary conditions whereby it may…
This inspection in context
Christopher D. Leach
11 documents · 2013–2018
Cites 211.42 (design and construction features) 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 1 observation on this Form 483, mostly about production. 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?
Christopher D. Leach is named on this Form 483, for the inspection of Sep 1 – Sep 21, 2016. 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 Sep 1 – Sep 21, 2016, and the Form 483 is dated September 21, 2016.
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.