Baxalta US Inc.
FDA inspection history in Social Circle, Georgia, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Social Circle, Georgia.
Cited most
Across all Baxalta US observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.194Laboratory records1
- 21 CFR 600.14Reporting of biological product deviations by licensed manufacturers1
The complete Baxalta US file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Social Circle, Georgia
One Form 483 · 2021
Latest: Form 483, Jul 1, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-01 | 483 Form 483 | Social Circle, Georgia | — | $99 |
FEI number 3013980449 · most recent document Jul 1, 2021
About Baxalta US Inc.
How many FDA Form 483s has Baxalta US Inc. received?
FDA Intel has 1 Form 483 on file for Baxalta US Inc.; the most recent is dated Jul 1, 2021.
When was Baxalta US Inc. last inspected by FDA?
The most recent FDA inspection document on file for Baxalta US Inc. is a Form 483 dated Jul 1, 2021, for the site in Social Circle, Georgia.
What did FDA cite at Baxalta US Inc.?
The regulations cited most in the observations on file for Baxalta US Inc. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.194 (Laboratory records), 1 time; 21 CFR 600.14 (Reporting of biological product deviations by licensed manufacturers), 1 time.