Texas Medical Technology Inc
Form 483 issued March 3, 2022 · Houston, Texas
- Inspection
- Feb 16 – Mar 3, 2022
- Investigator
- Ellen J. Tave
- Observations
- 9
- Pages
- 10
- FEI number
- 3016808907
In short: On March 3, 2022, FDA issued a Form 483 with 9 observations to Texas Medical Technology Inc in Houston, Texas (FEI 3016808907) after an inspection that ran Feb 16 – Mar 3, 2022. The investigator was Ellen J. Tave. Most observations concern production & process controls and records & documents.
At a glance
Production & process controls and records & documents account for 7 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
A device master record has…
- 04
Procedmes for device history records have…
This inspection in context
Ellen J. Tave
8 documents · 2015–2024
Cites 820.30(g) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmTexas Medical Technology Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Texas Medical Technology Inc?
FDA listed 9 observations on this Form 483, mostly about production & process controls, records & documents and cAPA. The opening words of each observation are shown on this page.
Who inspected Texas Medical Technology Inc?
Ellen J. Tave is named on this Form 483, for the inspection of Feb 16 – Mar 3, 2022. Each investigator has a profile showing what they cite most.
When was Texas Medical Technology Inc inspected by FDA?
The inspection ran Feb 16 – Mar 3, 2022, and the Form 483 is dated March 3, 2022.
How do I get the full Form 483 for Texas Medical Technology 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.