International Isotopes Inc.
Form 483 issued May 10, 2019 · Idaho Falls, Idaho
- Inspection
- May 7 – May 10, 2019
- Investigator
- Farhana Khan
- Observations
- 6
- Pages
- 6
- FEI number
- 3003350319
In short: On May 10, 2019, FDA issued a Form 483 with 6 observations to International Isotopes Inc. in Idaho Falls, Idaho (FEI 3003350319) after an inspection that ran May 7 – May 10, 2019. The investigator was Farhana Khan. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
- 03
Each component is not tested for conformity with all appropriate written specifications for…
- 04
There is a failure to thoroughly review whether or not the batch…
This inspection in context
Farhana Khan
7 documents · 2016–2021
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmInternational Isotopes Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at International Isotopes Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected International Isotopes Inc.?
Farhana Khan is named on this Form 483, for the inspection of May 7 – May 10, 2019. Each investigator has a profile showing what they cite most.
When was International Isotopes Inc. inspected by FDA?
The inspection ran May 7 – May 10, 2019, and the Form 483 is dated May 10, 2019.
How do I get the full Form 483 for International Isotopes Inc.?
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.