MedisourceRx
Form 483 issued October 22, 2020 · Los Alamitos, California
- Inspection
- Oct 5 – Oct 22, 2020
- Investigator
- Liming Zhang
- Observations
- 7
- Pages
- 7
- FEI number
- 3013316698
In short: On October 22, 2020, FDA issued a Form 483 with 7 observations to MedisourceRx in Los Alamitos, California (FEI 3013316698) after an inspection that ran Oct 5 – Oct 22, 2020. The investigator was Liming Zhang. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 5 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Written production and process control procedures are not documented at…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) 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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MedisourceRx?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected MedisourceRx?
Liming Zhang is named on this Form 483, for the inspection of Oct 5 – Oct 22, 2020. Each investigator has a profile showing what they cite most.
When was MedisourceRx inspected by FDA?
The inspection ran Oct 5 – Oct 22, 2020, and the Form 483 is dated October 22, 2020.
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.