LED Technologies, Inc.
Form 483 issued June 30, 2016 · Centennial, Colorado
- Inspection
- Jun 17 – Jun 30, 2016
- Investigator
- Felix J. Marrero
- Observations
- 3
- Pages
- 2
- FEI number
- 3012420078
In short: On June 30, 2016, FDA issued a Form 483 with 3 observations to LED Technologies, Inc. in Centennial, Colorado (FEI 3012420078) after an inspection that ran Jun 17 – Jun 30, 2016. The investigator was Felix J. Marrero. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
3 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for finished device acceptance have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications…
- 03
Procedures for acceptance of incoming product…
This inspection in context
Felix J. Marrero
7 documents · 2011–2025
Cites 803 more than any other section. Most of their documents are for sites in Colorado.
The firmLED Technologies, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at LED Technologies, Inc.?
FDA listed 3 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected LED Technologies, Inc.?
Felix J. Marrero is named on this Form 483, for the inspection of Jun 17 – Jun 30, 2016. Each investigator has a profile showing what they cite most.
When was LED Technologies, Inc. inspected by FDA?
The inspection ran Jun 17 – Jun 30, 2016, and the Form 483 is dated June 30, 2016.
How do I get the full Form 483 for LED 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.