Triad Isotopes Inc.
Form 483 issued January 9, 2015 · Kansas City, Missouri
- Inspection
- Jan 5 – Jan 9, 2015
- Investigators
- James G. Flahive· Russell J. Glapion
- Observations
- 4
- Pages
- 3
- FEI number
- 3008364285
In short: On January 9, 2015, FDA issued a Form 483 with 4 observations to Triad Isotopes Inc. in Kansas City, Missouri (FEI 3008364285) after an inspection that ran Jan 5 – Jan 9, 2015. The investigators were James G. Flahive and Russell J. Glapion. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
The responsibilities and procedures applicable .to the quality control unit are not in…
This inspection in context
James G. Flahive
1 document · 2015
Cites 211.160(b) (general requirements) more than any other section. Most of their documents are for sites in Missouri.
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 211.28(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triad Isotopes Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Triad Isotopes Inc.?
James G. Flahive and Russell J. Glapion are named on this Form 483, for the inspection of Jan 5 – Jan 9, 2015. Each investigator has a profile showing what they cite most.
When was Triad Isotopes Inc. inspected by FDA?
The inspection ran Jan 5 – Jan 9, 2015, and the Form 483 is dated January 9, 2015.
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.