Trone Health Services, Inc.
Form 483 issued July 15, 2016 · Meridian, Idaho
- Inspection
- Jun 27 – Jul 15, 2016
- Investigators
- Nancy E. Byerly· Tracy K. Li
- Observations
- 6
- Pages
- 5
- FEI number
- 3012086997
In short: On July 15, 2016, FDA issued a Form 483 with 6 observations to Trone Health Services, Inc. in Meridian, Idaho (FEI 3012086997) after an inspection that ran Jun 27 – Jul 15, 2016. The investigators were Nancy E. Byerly and Tracy K. Li. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Separate or defmed areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
There is no written testing program designed to assess the stability…
- 03
Control procedm es fail to include adequacy of mixing to…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Nancy E. Byerly
7 documents · 2015–2017
Cites 211.42 (design and construction features) 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 211.42(c)(10)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Trone Health Services, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Trone Health Services, Inc.?
Nancy E. Byerly and Tracy K. Li are named on this Form 483, for the inspection of Jun 27 – Jul 15, 2016. Each investigator has a profile showing what they cite most.
When was Trone Health Services, Inc. inspected by FDA?
The inspection ran Jun 27 – Jul 15, 2016, and the Form 483 is dated July 15, 2016.
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.