MedisourceRx
FDA inspection history in Los Alamitos, California, 2018 to 2025
- 3
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2018: one Form 483; 2020: one Form 483; 2025: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–20Two Form 483s, at Los Alamitos, California.
- 2018The longest 483 on file: 7 observations over 10 pages at Los Alamitos, California.
- 2025One warning letter and one Form 483, at Los Alamitos, California.
Cited most
Across all MedisourceRx observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.192Production record review2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.186(b)(9)Master production and control records1
The complete MedisourceRx 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
Los Alamitos, California
Three Form 483s, one warning letter and one close-out letter · 2018 to 2025 · 16 observations
Latest: Warning letter, Dec 12, 2025 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-12 | Warning letter Warning letter | Los Alamitos, California | — | $99 |
| 2025-06-10 | 483 Form 483 | Los Alamitos, California | 2 | $99 |
| 2020-10-22 | 483 Form 483 | Los Alamitos, California | 7 | $99 |
| 2018-09-27 | 483 Form 483 | Los Alamitos, California | 7 | $99 |
| Undated | Close-out Close-out letter | Los Alamitos, California | — | $99 |
Investigators on these documents
Bryan A. Galvez (1)Liming Zhang (1)Sangeeta M. Khurana (1)Stephanie A. Slater (1)Tareq W. Haddad (1)
FEI number 3013316698 · most recent document Dec 12, 2025
About MedisourceRx
How many FDA Form 483s has MedisourceRx received?
FDA Intel has 3 Form 483s on file for MedisourceRx; the most recent is dated Jun 10, 2025.
When was MedisourceRx last inspected by FDA?
The most recent FDA inspection document on file for MedisourceRx is a Form 483 dated Jun 10, 2025, for the site in Los Alamitos, California.
What did FDA cite at MedisourceRx?
The regulations cited most in the observations on file for MedisourceRx are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.
Has MedisourceRx received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for MedisourceRx; the most recent is dated Dec 12, 2025.