TZ Medical, Inc.
FDA inspection history in Portland, Oregon, 2012 to 2016
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2012: one warning letter; 2015: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One warning letter, at Portland, Oregon.
- 2015–16Two Form 483s, at Portland, Oregon.
- 2015The longest 483 on file: 4 observations over 8 pages at Portland, Oregon.
Cited most
Across all TZ Medical observations on file
- 21 CFR 820.30Design controls2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.120Device labeling1
- 21 CFR 820.184Device history record1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
The complete TZ Medical file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Portland, Oregon
Two Form 483s and one warning letter · 2012 to 2016 · 7 observations
Latest: Form 483, Jul 13, 2016 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-07-13 | 483 Form 483 | Portland, Oregon | 3 | $99 |
| 2015-11-03 | 483 Form 483 | Portland, Oregon | 4 | $99 |
| 2012-04-10 | Warning letter Warning letter | Portland, Oregon | — | $99 |
Investigators on these documents
FEI number 1000127185 · most recent document Jul 13, 2016
About TZ Medical, Inc.
How many FDA Form 483s has TZ Medical, Inc. received?
FDA Intel has 2 Form 483s on file for TZ Medical, Inc.; the most recent is dated Jul 13, 2016.
When was TZ Medical, Inc. last inspected by FDA?
The most recent FDA inspection document on file for TZ Medical, Inc. is a Form 483 dated Jul 13, 2016, for the site in Portland, Oregon.
What did FDA cite at TZ Medical, Inc.?
The regulations cited most in the observations on file for TZ Medical, Inc. are 21 CFR 820.30 (Design controls), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.120 (Device labeling), 1 time.
Has TZ Medical, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for TZ Medical, Inc.; the most recent is dated Apr 10, 2012.