TZ Medical, Inc.
Form 483 issued November 3, 2015 · Portland, Oregon
- Inspection
- Oct 5 – Oct 15, 2015
- Investigator
- James D. Hildreth
- Observations
- 4
- Pages
- 8
- FEI number
- 1000127185
In short: On November 3, 2015, FDA issued a Form 483 with 4 observations to TZ Medical, Inc. in Portland, Oregon (FEI 1000127185) after an inspection that ran Oct 5 – Oct 15, 2015. The investigator was James D. Hildreth. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 3 of 4 observations.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design change have…
- 02
Procedures for design review have…
- 04
Specifically, •…
- 07
Procedures for corrective and preventive action have…
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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at TZ Medical, Inc.?
FDA listed 4 observations on this Form 483, mostly about design controls, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). 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 Oct 5 – Oct 15, 2015. Each investigator has a profile showing what they cite most.
When was TZ Medical, Inc. inspected by FDA?
The inspection ran Oct 5 – Oct 15, 2015, and the Form 483 is dated November 3, 2015.
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.