Nelson Environmental Technologies, Inc.
Form 483 issued January 24, 2022 · Stafford, Texas
- Inspection
- Dec 16, 2021 – Jan 24, 2022
- Investigator
- Ellen J. Tave
- Observations
- 10
- Pages
- 11
- FEI number
- 3010866895
In short: On January 24, 2022, FDA issued a Form 483 with 10 observations to Nelson Environmental Technologies, Inc. in Stafford, Texas (FEI 3010866895) after an inspection that ran Dec 16, 2021 – Jan 24, 2022. The investigator was Ellen J. Tave. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 8 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for acceptance of incoming product have…
- 04
Risk analysis was not…
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 firmNelson Environmental Technologies, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nelson Environmental Technologies, Inc.?
FDA listed 10 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Nelson Environmental Technologies, Inc.?
Ellen J. Tave is named on this Form 483, for the inspection of Dec 16, 2021 – Jan 24, 2022. Each investigator has a profile showing what they cite most.
When was Nelson Environmental Technologies, Inc. inspected by FDA?
The inspection ran Dec 16, 2021 – Jan 24, 2022, and the Form 483 is dated January 24, 2022.
How do I get the full Form 483 for Nelson Environmental Technologies, 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.