Alexander Infusion LLC dba Avanti Healthcare Services
Form 483 issued August 1, 2016 · New Hyde Park, New York
- Inspection
- Aug 1, 2016
- Investigator
- Jenny McAllister
- Observations
- 7
- Pages
- 3
- FEI number
- 3008846597
In short: On August 1, 2016, FDA issued a Form 483 with 7 observations to Alexander Infusion LLC dba Avanti Healthcare Services in New Hyde Park, New York (FEI 3008846597) after an inspection that ran Aug 1, 2016. The investigator was Jenny McAllister. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 3 systems, led by facilities & equipment.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the…
- 02
There is no written testing program designed to assess the stability…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Jenny McAllister
1 document · 2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAlexander Infusion LLC dba Avanti Healthcare Services history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alexander Infusion LLC dba Avanti Healthcare Services?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Alexander Infusion LLC dba Avanti Healthcare Services?
Jenny McAllister is named on this Form 483, for the inspection of Aug 1, 2016. Each investigator has a profile showing what they cite most.
When was Alexander Infusion LLC dba Avanti Healthcare Services inspected by FDA?
The inspection ran Aug 1, 2016, and the Form 483 is dated August 1, 2016.
How do I get the full Form 483 for Alexander Infusion LLC dba Avanti Healthcare Services?
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.