SCA Pharmaceuticals, LLC
FDA inspection history across 2 sites, 2014 to 2026
- 5
- Form 483s
- 2
- Warning letters
- 1
- Response
Every document, by year
- Warning letter
- Response
- Form 483
2014: one Form 483; 2015: one warning letter; 2017: one Form 483; 2019: one Form 483; 2023: one Form 483; 2025: one 483 response and one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–19Three Form 483s and one warning letter, at Little Rock, Arkansas.
- 2014The longest 483 on file: 8 observations over 8 pages at Little Rock, Arkansas.
- 2023–26Two Form 483s, one 483 response and one warning letter, at Little Rock, Arkansas and Little Roc k, Arkansas.
Cited most
Across all SCA Pharmaceuticals observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features7
- 21 CFR 211.192Production record review5
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.28(a)Personnel responsibilities2
- 21 CFR 211.134Drug product inspection1
The complete SCA Pharmaceuticals file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Little Rock, Arkansas
Four Form 483s, two warning letters and one 483 response · 2014 to 2026 · 24 observations
Latest: Warning letter, Sep 14, 2026 →Little Roc k, Arkansas
One Form 483 · 2025 · 4 observations
Latest: Form 483, Oct 30, 2025 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-09-14 | Warning letter Warning letter | Little Rock, Arkansas | — | $99 |
| 2025-11-21 | Response 483 response | Little Rock, Arkansas | — | $199 |
| 2025-10-30 | 483 Form 483 | Little Roc k, Arkansas | 4 | $99 |
| 2023-05-17 | 483 Form 483 | Little Rock, Arkansas | 4 | $99 |
| 2019-11-07 | 483 Form 483 | Little Rock, Arkansas | 6 | $99 |
| 2017-09-29 | 483 Form 483 | Little Rock, Arkansas | 6 | $99 |
| 2015-06-25 | Warning letter Warning letter | Little Rock, Arkansas | — | $99 |
| 2014-04-01 | 483 Form 483 | Little Rock, Arkansas | 8 | $99 |
Investigators on these documents
Claire M. Minden (2)Demario L. Walls (1)Lisa R. Hilliard (1)Margaret M. Annes (1)Megan Ziegler (1)Ninmy Mathews (1)Zachery L. Miller (1)
FEI number 3010683157 · most recent document Sep 14, 2026
About SCA Pharmaceuticals, LLC
How many FDA Form 483s has SCA Pharmaceuticals, LLC received?
FDA Intel has 5 Form 483s on file for SCA Pharmaceuticals, LLC; the most recent is dated Oct 30, 2025.
When was SCA Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for SCA Pharmaceuticals, LLC is a Form 483 dated Oct 30, 2025, for the site in Little Roc k, Arkansas.
What did FDA cite at SCA Pharmaceuticals, LLC?
The regulations cited most in the observations on file for SCA Pharmaceuticals, LLC are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 7 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times.
Has SCA Pharmaceuticals, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for SCA Pharmaceuticals, LLC; the most recent is dated Sep 14, 2026.