Swiss-American CDMO, LLC
FDA inspection history in Carrollton, Texas, 2008 to 2024
- 5
- Form 483s
Every document, by year
- Form 483
2008: one Form 483; 2018: one Form 483; 2022: two Form 483s; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One Form 483, at Carrollton, Texas.
- 2008The longest 483 on file: 15 observations over 7 pages at Carrollton, Texas.
- 2018One Form 483, at Carrollton, Texas.
- 2022–24Three Form 483s, at Carrollton, Texas.
Cited most
Across all Swiss-American CDMO observations on file
- 21 CFR 820.30Design controls7
- 21 CFR 820.70Production and process controls3
- 21 CFR 820.75Process validation3
- 21 CFR 211.101(b)(1)Charge-in of components1
- 21 CFR 211.142(b)Warehousing procedures1
The complete Swiss-American CDMO file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Carrollton, Texas
Five Form 483s · 2008 to 2024 · 30 observations
Latest: Form 483, Dec 16, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-16 | 483 Form 483 | Carrollton, Texas | 2 | $99 |
| 2022-12-19 | 483 Form 483 | Carrollton, Texas | 4 | $99 |
| 2022-03-31 | 483 Form 483 | Carrollton, Texas | 8 | $99 |
| 2018-09-28 | 483 Form 483 | Carrollton, Texas | 1 | $99 |
| 2008-09-04 | 483 Form 483 | Carrollton, Texas | 15 | $99 |
Investigators on these documents
Elizabeth A. Krolczyk (1)Jessica M. Simpson (1)Jude C. Dike (1)Margaret M. Annes (1)Patty P. Kaewussdangkul (1)Shanna N. Purdy (1)
FEI number 3001451826 · most recent document Dec 16, 2024
About Swiss-American CDMO, LLC
How many FDA Form 483s has Swiss-American CDMO, LLC received?
FDA Intel has 5 Form 483s on file for Swiss-American CDMO, LLC; the most recent is dated Dec 16, 2024.
When was Swiss-American CDMO, LLC last inspected by FDA?
The most recent FDA inspection document on file for Swiss-American CDMO, LLC is a Form 483 dated Dec 16, 2024, for the site in Carrollton, Texas.
What did FDA cite at Swiss-American CDMO, LLC?
The regulations cited most in the observations on file for Swiss-American CDMO, LLC are 21 CFR 820.30 (Design controls), 7 times; 21 CFR 820.70 (Production and process controls), 3 times; 21 CFR 820.75 (Process validation), 3 times.