International Medication Systems, Ltd.
Form 483 issued February 15, 2023 · South El Monte, California
- Inspection
- Feb 6 – Feb 15, 2023
- Investigator
- Khoa Nathan V. Tran
- Observations
- 2
- Pages
- 5
- FEI number
- 2016148
In short: On February 15, 2023, FDA issued a Form 483 with 2 observations to International Medication Systems, Ltd. in South El Monte, California (FEI 2016148) after an inspection that ran Feb 6 – Feb 15, 2023. The investigator was Khoa Nathan V. Tran. Most observations concern facilities & equipment and production & process controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 820.70 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 02
Schedules for the adjustment, cleaning, and other maintenance of equipment…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmInternational Medication Systems, Ltd. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Medication Systems, Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production & process controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected International Medication Systems, Ltd.?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Feb 6 – Feb 15, 2023. Each investigator has a profile showing what they cite most.
When was International Medication Systems, Ltd. inspected by FDA?
The inspection ran Feb 6 – Feb 15, 2023, and the Form 483 is dated February 15, 2023.
How do I get the full Form 483 for International Medication Systems, Ltd.?
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.