Seniorlife Technologies Inc.
Form 483 issued February 20, 2026 · Bellevue, Washington
- Inspection
- Feb 17 – Feb 20, 2026
- Investigators
- Brian R. Hendricks· Kevin T. Le
- Observations
- 6
- Pages
- 6
- FEI number
- 3027535342
In short: On February 20, 2026, FDA issued a Form 483 with 6 observations to Seniorlife Technologies Inc. in Bellevue, Washington (FEI 3027535342) after an inspection that ran Feb 17 – Feb 20, 2026. The investigators were Brian R. Hendricks and Kevin T. Le. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.10 (requirements for a quality management system).
At a glance
4 of 6 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.10 (4×) · 830.300 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A system to assign unique device identification (UDI) to the medical…
- 02
Design and development procedures…
- 03
Procedures for validation of processes did not adequately include requirements for records and use of specific…
- 04
Outsourced processes that affect product conformity to requirements were…
This inspection in context
Brian R. Hendricks
6 documents · 2024–2026
Cites 820.10 (requirements for a quality management system) more than any other section. Most of their documents are for sites in Washington.
The firmSeniorlife Technologies 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 820.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Seniorlife Technologies Inc.?
FDA listed 6 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.10 (requirements for a quality management system). The opening words of each observation are shown on this page.
Who inspected Seniorlife Technologies Inc.?
Brian R. Hendricks and Kevin T. Le are named on this Form 483, for the inspection of Feb 17 – Feb 20, 2026. Each investigator has a profile showing what they cite most.
When was Seniorlife Technologies Inc. inspected by FDA?
The inspection ran Feb 17 – Feb 20, 2026, and the Form 483 is dated February 20, 2026.
How do I get the full Form 483 for Seniorlife 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.