Athenex Pharma Solutions, LLC
Form 483 issued August 28, 2019 · Clarence, New York
- Inspection
- Aug 19 – Aug 28, 2019
- Investigator
- Tonia F. Bernard
- Observations
- 1
- Pages
- 2
- FEI number
- 3008876196
In short: On August 28, 2019, FDA issued a Form 483 with 1 observation to Athenex Pharma Solutions, LLC in Clarence, New York (FEI 3008876196) after an inspection that ran Aug 19 – Aug 28, 2019. The investigator was Tonia F. Bernard. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Tonia F. Bernard
13 documents · 2016–2024
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
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 211.100
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 production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Athenex Pharma Solutions, LLC?
Tonia F. Bernard is named on this Form 483, for the inspection of Aug 19 – Aug 28, 2019. Each investigator has a profile showing what they cite most.
When was Athenex Pharma Solutions, LLC inspected by FDA?
The inspection ran Aug 19 – Aug 28, 2019, and the Form 483 is dated August 28, 2019.
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.