Transtracheal Systems, Inc
Form 483 issued September 17, 2020 · Englewood, Colorado
- Inspection
- Sep 2 – Sep 17, 2020
- Investigator
- Christine I. Shaw
- Observations
- 6
- Pages
- 11
- FEI number
- 1721097
In short: On September 17, 2020, FDA issued a Form 483 with 6 observations to Transtracheal Systems, Inc in Englewood, Colorado (FEI 1721097) after an inspection that ran Sep 2 – Sep 17, 2020. The investigator was Christine I. Shaw. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for corrective and preventive action have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures to control labeling activities have…
This inspection in context
Christine I. Shaw
8 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.
The firmTranstracheal Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Transtracheal Systems, Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected Transtracheal Systems, Inc?
Christine I. Shaw is named on this Form 483, for the inspection of Sep 2 – Sep 17, 2020. Each investigator has a profile showing what they cite most.
When was Transtracheal Systems, Inc inspected by FDA?
The inspection ran Sep 2 – Sep 17, 2020, and the Form 483 is dated September 17, 2020.
How do I get the full Form 483 for Transtracheal Systems, 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.