Societal CDMO Gainesville, LLC
FDA inspection history in Gainesville, Georgia, 2019 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Gainesville, Georgia.
- 2019The longest 483 on file: 2 observations over 3 pages at Gainesville, Georgia.
- 2024One Form 483, at Gainesville, Georgia.
Cited most
Across all Societal CDMO Gainesville observations on file
- 21 CFR 211.192Production record review1
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment1
The complete Societal CDMO Gainesville 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
Gainesville, Georgia
Two Form 483s · 2019 to 2024 · 3 observations
Latest: Form 483, Nov 19, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-19 | 483 Form 483 | Gainesville, Georgia | 1 | $99 |
| 2019-08-12 | 483 Form 483 | Gainesville, Georgia | 2 | $99 |
Investigators on these documents
FEI number 1035761 · most recent document Nov 19, 2024
About Societal CDMO Gainesville, LLC
How many FDA Form 483s has Societal CDMO Gainesville, LLC received?
FDA Intel has 2 Form 483s on file for Societal CDMO Gainesville, LLC; the most recent is dated Nov 19, 2024.
When was Societal CDMO Gainesville, LLC last inspected by FDA?
The most recent FDA inspection document on file for Societal CDMO Gainesville, LLC is a Form 483 dated Nov 19, 2024, for the site in Gainesville, Georgia.
What did FDA cite at Societal CDMO Gainesville, LLC?
The regulations cited most in the observations on file for Societal CDMO Gainesville, LLC are 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.194 (Laboratory records), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.