Athenex Pharma Solutions, LLC
Form 483 issued December 13, 2017 · Clarence, New York
- Inspection
- Dec 5 – Dec 13, 2017
- Investigator
- Rachael Moliver
- Observations
- 4
- Pages
- 3
- FEI number
- 3008876196
In short: On December 13, 2017, FDA issued a Form 483 with 4 observations to Athenex Pharma Solutions, LLC in Clarence, New York (FEI 3008876196) after an inspection that ran Dec 5 – Dec 13, 2017. The investigator was Rachael Moliver. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing…
- 04FDCA 503B(a)(10)
The labels of your outsourcing facility's…
This inspection in context
Rachael Moliver
13 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAthenex Pharma Solutions, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Athenex Pharma Solutions, LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment. 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 Athenex Pharma Solutions, LLC?
Rachael Moliver is named on this Form 483, for the inspection of Dec 5 – Dec 13, 2017. Each investigator has a profile showing what they cite most.
When was Athenex Pharma Solutions, LLC inspected by FDA?
The inspection ran Dec 5 – Dec 13, 2017, and the Form 483 is dated December 13, 2017.
How do I get the full Form 483 for Athenex Pharma Solutions, LLC?
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.