Option Care Enterprises
FDA inspection history in Columbia, Maryland, 2016 to 2020
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2016: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Columbia, Maryland.
- 2020One close-out letter, at Columbia, Maryland.
Cited most
Across all Option Care Enterprises observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Option Care Enterprises file.
All 2 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
Columbia, Maryland
One close-out letter and one Form 483 · 2016 to 2020 · 5 observations
Latest: Close-out, Apr 23, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-04-23 | Close-out Close-out letter | Columbia, Maryland | — | $99 |
| 2016-06-28 | 483 Form 483 | Columbia, Maryland | 5 | $99 |
Investigators on these documents
FEI number 3012335395 · most recent document Apr 23, 2020
About Option Care Enterprises
How many FDA Form 483s has Option Care Enterprises received?
FDA Intel has 1 Form 483 on file for Option Care Enterprises; the most recent is dated Jun 28, 2016.
When was Option Care Enterprises last inspected by FDA?
The most recent FDA inspection document on file for Option Care Enterprises is a Form 483 dated Jun 28, 2016, for the site in Columbia, Maryland.
What did FDA cite at Option Care Enterprises?
The regulations cited most in the observations on file for Option Care Enterprises are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.28(a) (Personnel responsibilities), 1 time.