TZ Medical, Inc.
Form 483 issued July 13, 2016 · Portland, Oregon
- Inspection
- Jul 6 – Jul 13, 2016
- Investigator
- James D. Hildreth
- Observations
- 3
- Pages
- 3
- FEI number
- 1000127185
In short: On July 13, 2016, FDA issued a Form 483 with 3 observations to TZ Medical, Inc. in Portland, Oregon (FEI 1000127185) after an inspection that ran Jul 6 – Jul 13, 2016. The investigator was James D. Hildreth. Most observations concern production & process controls and records & documents; the most-cited regulation is 21 CFR 820.120 (device labeling).
At a glance
Production & process controls and records & documents account for 2 of 3 observations.
Most cited: 21 CFR 820.120 (1×) · 820.184 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control labeling activities have…
- 02
A device history record has…
- 03
: Promised to correct…
This inspection in context
James D. Hildreth
6 documents · 2011–2016
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Oregon.
The firmTZ Medical, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.120
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TZ Medical, Inc.?
FDA listed 3 observations on this Form 483, mostly about production & process controls and records & documents. The most-cited regulation is 21 CFR 820.120 (device labeling). The opening words of each observation are shown on this page.
Who inspected TZ Medical, Inc.?
James D. Hildreth is named on this Form 483, for the inspection of Jul 6 – Jul 13, 2016. Each investigator has a profile showing what they cite most.
When was TZ Medical, Inc. inspected by FDA?
The inspection ran Jul 6 – Jul 13, 2016, and the Form 483 is dated July 13, 2016.
How do I get the full Form 483 for TZ Medical, 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.