SCA Phar maceutical s , LLC
FDA inspection history across 3 sites, 2018 to 2026
- 6
- Form 483s
- 1
- Response
Every document, by year
- Form 483
- Response
2018: one Form 483; 2019: one Form 483; 2023: one 483 response and one Form 483; 2024: two Form 483s; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s, at Windsor, Connecticut.
- 2018The longest 483 on file: 11 observations over 7 pages at Windsor, Connecticut.
- 2023–26Four Form 483s and one 483 response, at Connecticut; Windsor, Connecticut and Windso r, Connecticut.
Cited most
Across all SCA Phar maceutical s observations on file
- 21 CFR 211.113Control of microbiological contamination7
- 21 CFR 211.192Production record review6
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.100Written procedures; deviations2
The complete SCA Phar maceutical s file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Windsor, Connecticut
Five Form 483s · 2018 to 2024 · 37 observations
Latest: Form 483, Dec 20, 2024 →Windso r, Connecticut
One Form 483 · 2026 · 3 observations
Latest: Form 483, Mar 13, 2026 →Connecticut
One 483 response · 2023
Latest: Response, Nov 10, 2023 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-13 | 483 Form 483 | Windso r, Connecticut | 3 | $99 |
| 2024-12-20 | 483 Form 483 | Windsor, Connecticut | 7 | $99 |
| 2024-02-20 | 483 Form 483 | Windsor, Connecticut | 7 | $99 |
| 2023-11-10 | Response 483 response | Connecticut | — | $199 |
| 2023-10-20 | 483 Form 483 | Windsor, Connecticut | 10 | $99 |
| 2019-11-19 | 483 Form 483 | Windsor, Connecticut | 2 | $99 |
| 2018-03-05 | 483 Form 483 | Windsor, Connecticut | 11 | $99 |
Investigators on these documents
Samir C. Gala (2)Jazmine N. Brown (2)Jonah S. Ufferfilge (1)Jonathan G. Matrisciano (1)Robert J. Martin (1)Dien N. Nguyen (1)Simone E. Pitts (1)John P. Mistler (1)
FEI number 3013736415 · most recent document Mar 13, 2026
About SCA Phar maceutical s , LLC
How many FDA Form 483s has SCA Phar maceutical s , LLC received?
FDA Intel has 6 Form 483s on file for SCA Phar maceutical s , LLC; the most recent is dated Mar 13, 2026.
When was SCA Phar maceutical s , LLC last inspected by FDA?
The most recent FDA inspection document on file for SCA Phar maceutical s , LLC is a Form 483 dated Mar 13, 2026, for the site in Windso r, Connecticut.
What did FDA cite at SCA Phar maceutical s , LLC?
The regulations cited most in the observations on file for SCA Phar maceutical s , LLC are 21 CFR 211.113 (Control of microbiological contamination), 7 times; 21 CFR 211.192 (Production record review), 6 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 5 times.