Athenex Pharma Solutions, LLC
Form 483 issued September 16, 2022 · Clarence, New York
- Inspection
- Sep 8 – Sep 16, 2022
- Investigators
- Junho Pak· Syeda N. Mahazabin
- Observations
- 1
- Pages
- 3
- FEI number
- 3008876196
In short: On September 16, 2022, FDA issued a Form 483 with 1 observation to Athenex Pharma Solutions, LLC in Clarence, New York (FEI 3008876196) after an inspection that ran Sep 8 – Sep 16, 2022. The investigators were Junho Pak and Syeda N. Mahazabin. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Athenex Pharma Solutions, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Athenex Pharma Solutions, LLC?
Junho Pak and Syeda N. Mahazabin are named on this Form 483, for the inspection of Sep 8 – Sep 16, 2022. Each investigator has a profile showing what they cite most.
When was Athenex Pharma Solutions, LLC inspected by FDA?
The inspection ran Sep 8 – Sep 16, 2022, and the Form 483 is dated September 16, 2022.
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.