Option Care Enterprises Inc. dba Option Care
FDA inspection history across 4 sites, 2016 to 2019
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2016: one Form 483; 2017: one warning letter; 2018: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Two Form 483s, one warning letter and one close-out letter, at Wood Dale, Illinois; Bannockburn, Illinois; WoodDale, Illinois and one other site.
- 2018The longest 483 on file: 4 observations over 2 pages at WoodDale, Illinois.
Cited most
Across all Option Care Enterprises Inc. dba Option Care observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.42Design and construction features1
The complete Option Care Enterprises Inc. dba Option Care file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Little Rock, Arkansas
One close-out letter · 2019
Latest: Close-out, Dec 20, 2019 →WoodDale, Illinois
One Form 483 · 2018 · 4 observations
Latest: Form 483, Feb 8, 2018 →Bannockburn, Illinois
One warning letter · 2017
Latest: Warning letter, Sep 28, 2017 →Wood Dale, Illinois
One Form 483 · 2016 · 1 observation
Latest: Form 483, Sep 21, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-20 | Close-out Close-out letter | Little Rock, Arkansas | — | $99 |
| 2018-02-08 | 483 Form 483 | WoodDale, Illinois | 4 | $99 |
| 2017-09-28 | Warning letter Warning letter | Bannockburn, Illinois | — | $99 |
| 2016-09-21 | 483 Form 483 | Wood Dale, Illinois | 1 | $99 |
Investigators on these documents
FEI number 3012188090 · most recent document Dec 20, 2019
About Option Care Enterprises Inc. dba Option Care
How many FDA Form 483s has Option Care Enterprises Inc. dba Option Care received?
FDA Intel has 2 Form 483s on file for Option Care Enterprises Inc. dba Option Care; the most recent is dated Feb 8, 2018.
When was Option Care Enterprises Inc. dba Option Care last inspected by FDA?
The most recent FDA inspection document on file for Option Care Enterprises Inc. dba Option Care is a Form 483 dated Feb 8, 2018, for the site in WoodDale, Illinois.
What did FDA cite at Option Care Enterprises Inc. dba Option Care?
The regulations cited most in the observations on file for Option Care Enterprises Inc. dba Option Care are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.28 (Personnel responsibilities), 1 time; 21 CFR 211.42 (Design and construction features), 1 time.
Has Option Care Enterprises Inc. dba Option Care received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Option Care Enterprises Inc. dba Option Care; the most recent is dated Sep 28, 2017.