Vision Chips, Inc
Form 483 issued February 27, 2026 · Laguna Niguel, California
- Inspection
- Feb 26 – Feb 27, 2026
- Investigators
- Alexandria L. Capuano· Tyler J. Chia
- Observations
- 1
- Pages
- 3
- FEI number
- 3001237826
In short: On February 27, 2026, FDA issued a Form 483 with 1 observation to Vision Chips, Inc in Laguna Niguel, California (FEI 3001237826) after an inspection that ran Feb 26 – Feb 27, 2026. The investigators were Alexandria L. Capuano and Tyler J. Chia. The most-cited regulation is 21 CFR 801.20 (label to bear a unique device identifier).
What FDA observed
Preview: the opening words of each observation- 0121 CFR 801.20(a)21 CFR 830
The labels of the medical device(s) do not bear a unique device identifier (UDI) that meet…
This inspection in context
Alexandria L. Capuano
6 documents · 2022–2026
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in California.
The firmVision Chips, 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 801.20(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Vision Chips, Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 801.20 (label to bear a unique device identifier). The opening words of each observation are shown on this page.
Who inspected Vision Chips, Inc?
Alexandria L. Capuano and Tyler J. Chia are named on this Form 483, for the inspection of Feb 26 – Feb 27, 2026. Each investigator has a profile showing what they cite most.
When was Vision Chips, Inc inspected by FDA?
The inspection ran Feb 26 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.
How do I get the full Form 483 for Vision Chips, 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.