Trone Health Services, Inc.
Form 483 issued December 8, 2017 · Meridian, Idaho
- Inspection
- Oct 30 – Nov 21, 2017
- Investigators
- Kenneth O. Gee· Tracy K. Li
- Observations
- 2
- Pages
- 1
- FEI number
- 3012086997
In short: On December 8, 2017, FDA issued a Form 483 with 2 observations to Trone Health Services, Inc. in Meridian, Idaho (FEI 3012086997) after an inspection that ran Oct 30 – Nov 21, 2017. The investigators were Kenneth O. Gee and Tracy K. Li. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 1 system, led by materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-pharmaceutical grade components are used in the formation of non-sterile drug products. Spe·cifically, You.r ti.rm ha.s…
- 02
Your firm has not conducted any testing (microbial and analytical) of the water generated through the…
This inspection in context
Kenneth O. Gee
9 documents · 2017–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Washington.
The firmTrone Health Services, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Trone Health Services, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Trone Health Services, Inc.?
Kenneth O. Gee and Tracy K. Li are named on this Form 483, for the inspection of Oct 30 – Nov 21, 2017. Each investigator has a profile showing what they cite most.
When was Trone Health Services, Inc. inspected by FDA?
The inspection ran Oct 30 – Nov 21, 2017, and the Form 483 is dated December 8, 2017.
How do I get the full Form 483 for Trone Health Services, 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.