AltaThera Pharmaceuticals LLC
FDA inspection history in Chicago, Illinois, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Chicago, Illinois.
- 2022One Form 483, at Chicago, Illinois.
- 2022The longest 483 on file: 4 observations over 4 pages at Chicago, Illinois.
Cited most
Across all AltaThera Pharmaceuticals observations on file
- 21 CFR 314.80(b)Postmarketing reporting of adverse drug experiences3
- 21 CFR 211.22(a)Responsibilities of quality control unit1
- 21 CFR 314.81(b)(2)Other postmarketing reports1
The complete AltaThera Pharmaceuticals file.
All 2 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
Chicago, Illinois
Two Form 483s · 2019 to 2022 · 5 observations
Latest: Form 483, Jun 17, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-06-17 | 483 Form 483 | Chicago, Illinois | 4 | $99 |
| 2019-09-19 | 483 Form 483 | Chicago, Illinois | 1 | $99 |
Investigators on these documents
Alan M. Roberts (1)Colleen E. Burke (1)Jeanne J. Thai (1)Peng Zhou (1)Yuanyuan Li (1)
FEI number 3013989010 · most recent document Jun 17, 2022
About AltaThera Pharmaceuticals LLC
How many FDA Form 483s has AltaThera Pharmaceuticals LLC received?
FDA Intel has 2 Form 483s on file for AltaThera Pharmaceuticals LLC; the most recent is dated Jun 17, 2022.
When was AltaThera Pharmaceuticals LLC last inspected by FDA?
The most recent FDA inspection document on file for AltaThera Pharmaceuticals LLC is a Form 483 dated Jun 17, 2022, for the site in Chicago, Illinois.
What did FDA cite at AltaThera Pharmaceuticals LLC?
The regulations cited most in the observations on file for AltaThera Pharmaceuticals LLC are 21 CFR 314.80(b) (Postmarketing reporting of adverse drug experiences), 3 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 1 time; 21 CFR 314.81(b)(2) (Other postmarketing reports), 1 time.