Triad Isotopes Inc.
Form 483 issued July 3, 2017 · Kansas City, Missouri
- Inspection
- Jun 26 – Jul 3, 2017
- Investigator
- Michele L. Obert
- Observations
- 5
- Pages
- 1
- FEI number
- 3008364285
In short: On July 3, 2017, FDA issued a Form 483 with 5 observations to Triad Isotopes Inc. in Kansas City, Missouri (FEI 3008364285) after an inspection that ran Jun 26 – Jul 3, 2017. The investigator was Michele L. Obert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
3 of 5 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (3×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Your fnm is not using a sporicidal agent in the ISO 5 areas used…
- 03
Your fnm is using non-sterile disinfectants in the ISO 5 areas used for…
- 04
Your firm does not perform any contact sampling on the permanent equipment in the ISO 5…
This inspection in context
Michele L. Obert
6 documents · 2012–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kansas.
The firmTriad Isotopes Inc. 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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triad Isotopes Inc.?
FDA listed 5 observations on this Form 483, mostly about production 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 Triad Isotopes Inc.?
Michele L. Obert is named on this Form 483, for the inspection of Jun 26 – Jul 3, 2017. Each investigator has a profile showing what they cite most.
When was Triad Isotopes Inc. inspected by FDA?
The inspection ran Jun 26 – Jul 3, 2017, and the Form 483 is dated July 3, 2017.
How do I get the full Form 483 for Triad 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.