Athenex Pharma Solutions, LLC
FDA inspection history across 2 sites, 2017 to 2022
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one Form 483; 2019: one Form 483 and one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s and one warning letter, at Clarence, New York and New York.
- 2017The longest 483 on file: 4 observations over 3 pages at Clarence, New York.
- 2022One Form 483, at Clarence, New York.
Cited most
Across all Athenex Pharma Solutions observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.46(b)Ventilation, air filtration, air heating and cooling1
- FDCA 503B(a)(10)1
The complete Athenex Pharma Solutions file.
All 4 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
Clarence, New York
Three Form 483s · 2017 to 2022 · 6 observations
Latest: Form 483, Sep 16, 2022 →New York
One warning letter · 2019
Latest: Warning letter, Feb 19, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-16 | 483 Form 483 | Clarence, New York | 1 | $99 |
| 2019-08-28 | 483 Form 483 | Clarence, New York | 1 | $99 |
| 2019-02-19 | Warning letter Warning letter | New York | — | $99 |
| 2017-12-13 | 483 Form 483 | Clarence, New York | 4 | $99 |
Investigators on these documents
Junho Pak (1)Rachael Moliver (1)Syeda N. Mahazabin (1)Tonia F. Bernard (1)
FEI number 3008876196 · most recent document Sep 16, 2022
About Athenex Pharma Solutions, LLC
How many FDA Form 483s has Athenex Pharma Solutions, LLC received?
FDA Intel has 3 Form 483s on file for Athenex Pharma Solutions, LLC; the most recent is dated Sep 16, 2022.
When was Athenex Pharma Solutions, LLC last inspected by FDA?
The most recent FDA inspection document on file for Athenex Pharma Solutions, LLC is a Form 483 dated Sep 16, 2022, for the site in Clarence, New York.
What did FDA cite at Athenex Pharma Solutions, LLC?
The regulations cited most in the observations on file for Athenex Pharma Solutions, LLC are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Athenex Pharma Solutions, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Athenex Pharma Solutions, LLC; the most recent is dated Feb 19, 2019.