Triad Isotopes Inc.
FDA inspection history across 2 sites, 2015 to 2018
- 3
- Warning letters
- 2
- Form 483s
Every document, by year
- Warning letter
- Form 483
2015: one warning letter and one Form 483; 2016: one warning letter; 2017: one Form 483; 2018: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Three warning letters and two Form 483s, at Orlando, Florida and Kansas City, Missouri.
- 2015The longest 483 on file: 4 observations over 3 pages at Kansas City, Missouri.
Cited most
Across all Triad Isotopes observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Triad Isotopes file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Kansas City, Missouri
Two warning letters and two Form 483s · 2015 to 2018 · 8 observations
Latest: Warning letter, May 3, 2018 →Orlando, Florida
One warning letter · 2015
Latest: Warning letter, Mar 10, 2015 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-05-03 | Warning letter Warning letter | Kansas City, Missouri | — | $99 |
| 2017-07-03 | 483 Form 483 | Kansas City, Missouri | 4 | $99 |
| 2016-03-10 | Warning letter Warning letter | Kansas City, Missouri | — | $99 |
| 2015-03-10 | Warning letter Warning letter | Orlando, Florida | — | $99 |
| 2015-01-09 | 483 Form 483 | Kansas City, Missouri | 4 | $99 |
Investigators on these documents
James G. Flahive (1)Michele L. Obert (1)Russell J. Glapion (1)
FEI number 3008364285 · most recent document May 3, 2018
About Triad Isotopes Inc.
How many FDA Form 483s has Triad Isotopes Inc. received?
FDA Intel has 2 Form 483s on file for Triad Isotopes Inc.; the most recent is dated Jul 3, 2017.
When was Triad Isotopes Inc. last inspected by FDA?
The most recent FDA inspection document on file for Triad Isotopes Inc. is a Form 483 dated Jul 3, 2017, for the site in Kansas City, Missouri.
What did FDA cite at Triad Isotopes Inc.?
The regulations cited most in the observations on file for Triad Isotopes Inc. are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.160(b) (General requirements), 1 time.
Has Triad Isotopes Inc. received an FDA warning letter?
Yes. FDA Intel has 3 FDA warning letters on file for Triad Isotopes Inc.; the most recent is dated May 3, 2018.