International Medication Systems, Ltd.
Form 483 issued May 25, 2022 · South El Monte, California
- Inspection
- May 17 – May 25, 2022
- Investigator
- Nicholas L. Hunt
- Observations
- 1
- Pages
- 2
- FEI number
- 2016148
In short: On May 25, 2022, FDA issued a Form 483 with 1 observation to International Medication Systems, Ltd. in South El Monte, California (FEI 2016148) after an inspection that ran May 17 – May 25, 2022. The investigator was Nicholas L. Hunt. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Deviations from written production and process control procedures are…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
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 211.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Medication Systems, Ltd.?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected International Medication Systems, Ltd.?
Nicholas L. Hunt is named on this Form 483, for the inspection of May 17 – May 25, 2022. Each investigator has a profile showing what they cite most.
When was International Medication Systems, Ltd. inspected by FDA?
The inspection ran May 17 – May 25, 2022, and the Form 483 is dated May 25, 2022.
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.