Infusion Options, Inc.
FDA inspection history in Brooklyn, New York, 2014 to 2021
- 3
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2014: one Form 483; 2016: one warning letter; 2017: one Form 483; 2020: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Two Form 483s and one warning letter, at Brooklyn, New York.
- 2020–21One Form 483 and one warning letter, at Brooklyn, New York.
- 2020The longest 483 on file: 17 observations over 10 pages at Brooklyn, New York.
Cited most
Across all Infusion Options observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.167Special testing requirements3
- 21 CFR 211.28Personnel responsibilities3
The complete Infusion Options file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Brooklyn, New York
Three Form 483s and two warning letters · 2014 to 2021 · 37 observations
Latest: Warning letter, Aug 26, 2021 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-26 | Warning letter Warning letter | Brooklyn, New York | — | $99 |
| 2020-06-25 | 483 Form 483 | Brooklyn, New York | 17 | $99 |
| 2017-06-01 | 483 Form 483 | Brooklyn, New York | 7 | $99 |
| 2016-03-21 | Warning letter Warning letter | Brooklyn, New York | — | $99 |
| 2014-04-23 | 483 Form 483 | Brooklyn, New York | 13 | $99 |
Investigators on these documents
D. Jenny Xiradakis (1)James A. Liubicich (1)Jose O. Hernandez (1)Kevin J. Flessa (1)Robert C. Horan (1)
FEI number 3008231170 · most recent document Aug 26, 2021
About Infusion Options, Inc.
How many FDA Form 483s has Infusion Options, Inc. received?
FDA Intel has 3 Form 483s on file for Infusion Options, Inc.; the most recent is dated Jun 25, 2020.
When was Infusion Options, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Infusion Options, Inc. is a Form 483 dated Jun 25, 2020, for the site in Brooklyn, New York.
What did FDA cite at Infusion Options, Inc.?
The regulations cited most in the observations on file for Infusion Options, Inc. are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.165 (Testing and release for distribution), 3 times.
Has Infusion Options, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Infusion Options, Inc.; the most recent is dated Aug 26, 2021.