Pharmalogic Austin LLC
FDA inspection history in Austin, Texas, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Austin, Texas.
Cited most
Across all Pharmalogic Austin observations on file
- 21 CFR 211.188Batch production and control records2
- 21 CFR 211.166Stability testing1
- 21 CFR 211.67Equipment cleaning and maintenance1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Pharmalogic Austin file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Austin, Texas
One Form 483 · 2024 · 5 observations
Latest: Form 483, Nov 21, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-21 | 483 Form 483 | Austin, Texas | 5 | $99 |
Investigators on these documents
FEI number 3029262794 · most recent document Nov 21, 2024
About Pharmalogic Austin LLC
How many FDA Form 483s has Pharmalogic Austin LLC received?
FDA Intel has 1 Form 483 on file for Pharmalogic Austin LLC; the most recent is dated Nov 21, 2024.
When was Pharmalogic Austin LLC last inspected by FDA?
The most recent FDA inspection document on file for Pharmalogic Austin LLC is a Form 483 dated Nov 21, 2024, for the site in Austin, Texas.
What did FDA cite at Pharmalogic Austin LLC?
The regulations cited most in the observations on file for Pharmalogic Austin LLC are 21 CFR 211.188 (Batch production and control records), 2 times; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.