MedisourceRx
Form 483 issued June 10, 2025 · Los Alamitos, California
- Inspection
- May 27 – Jun 10, 2025
- Investigators
- Sangeeta M. Khurana· Tareq W. Haddad
- Observations
- 2
- Pages
- 3
- FEI number
- 3013316698
In short: On June 10, 2025, FDA issued a Form 483 with 2 observations to MedisourceRx in Los Alamitos, California (FEI 3013316698) after an inspection that ran May 27 – Jun 10, 2025. The investigators were Sangeeta M. Khurana and Tareq W. Haddad. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 310.305 (records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications).
At a glance
Observations span 1 system, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Adverse dnig experience information lias not…
- 02
Buildings used in the manufacture, processing, packing or holding of ding products are not free of…
This inspection in context
Sangeeta M. Khurana
20 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmMedisourceRx history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 310.305(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedisourceRx?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 310.305 (records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications). The opening words of each observation are shown on this page.
Who inspected MedisourceRx?
Sangeeta M. Khurana and Tareq W. Haddad are named on this Form 483, for the inspection of May 27 – Jun 10, 2025. Each investigator has a profile showing what they cite most.
When was MedisourceRx inspected by FDA?
The inspection ran May 27 – Jun 10, 2025, and the Form 483 is dated June 10, 2025.
How do I get the full Form 483 for MedisourceRx?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.