Societal CDMO San Diego, LLC
FDA inspection history in San Diego, California, 2021 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23Two Form 483s, at San Diego, California.
- 2021The longest 483 on file: 5 observations over 8 pages at San Diego, California.
Cited most
Across all Societal CDMO San Diego observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.42(a)Design and construction features1
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures1
The complete Societal CDMO San Diego 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
San Diego, California
Two Form 483s · 2021 to 2023 · 8 observations
Latest: Form 483, Jan 25, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-01-25 | 483 Form 483 | San Diego, California | 3 | $99 |
| 2021-04-07 | 483 Form 483 | San Diego, California | 5 | $99 |
Investigators on these documents
Santiago Gallardo Johnson (2)Nicholas L. Hunt (1)Rachel C. Stanton (1)
FEI number 3003600362 · most recent document Jan 25, 2023
About Societal CDMO San Diego, LLC
How many FDA Form 483s has Societal CDMO San Diego, LLC received?
FDA Intel has 2 Form 483s on file for Societal CDMO San Diego, LLC; the most recent is dated Jan 25, 2023.
When was Societal CDMO San Diego, LLC last inspected by FDA?
The most recent FDA inspection document on file for Societal CDMO San Diego, LLC is a Form 483 dated Jan 25, 2023, for the site in San Diego, California.
What did FDA cite at Societal CDMO San Diego, LLC?
The regulations cited most in the observations on file for Societal CDMO San Diego, LLC are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.