Alexander Infusion LLC dba Avanti Healthcare Services
FDA inspection history in New Hyde Park, New York, 2014 to 2016
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16Two Form 483s and one warning letter, at New Hyde Park, New York.
- 2014The longest 483 on file: 11 observations over 7 pages at New Hyde Park, New York.
Cited most
Across all Alexander Infusion LLC dba Avanti Healthcare Services observations on file
- 21 CFR 211.42Design and construction features7
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.167Special testing requirements2
- 21 CFR 211.28Personnel responsibilities2
The complete Alexander Infusion LLC dba Avanti Healthcare Services file.
All 3 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
New Hyde Park, New York
Two Form 483s and one warning letter · 2014 to 2016 · 18 observations
Latest: Form 483, Aug 1, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-08-01 | 483 Form 483 | New Hyde Park, New York | 7 | $99 |
| 2015-03-27 | Warning letter Warning letter | New Hyde Park, New York | — | $99 |
| 2014-07-09 | 483 Form 483 | New Hyde Park, New York | 11 | $99 |
Investigators on these documents
FEI number 3008846597 · most recent document Aug 1, 2016
About Alexander Infusion LLC dba Avanti Healthcare Services
How many FDA Form 483s has Alexander Infusion LLC dba Avanti Healthcare Services received?
FDA Intel has 2 Form 483s on file for Alexander Infusion LLC dba Avanti Healthcare Services; the most recent is dated Aug 1, 2016.
When was Alexander Infusion LLC dba Avanti Healthcare Services last inspected by FDA?
The most recent FDA inspection document on file for Alexander Infusion LLC dba Avanti Healthcare Services is a Form 483 dated Aug 1, 2016, for the site in New Hyde Park, New York.
What did FDA cite at Alexander Infusion LLC dba Avanti Healthcare Services?
The regulations cited most in the observations on file for Alexander Infusion LLC dba Avanti Healthcare Services are 21 CFR 211.42 (Design and construction features), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times.
Has Alexander Infusion LLC dba Avanti Healthcare Services received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Alexander Infusion LLC dba Avanti Healthcare Services; the most recent is dated Mar 27, 2015.