Thermo Electron LED GmbH
Form 483 issued March 20, 2025
- Inspection
- Mar 17 – Mar 20, 2025
- Investigator
- Stephen D. Eich
- Observations
- 2
- Pages
- 4
- FEI number
- 3005737891
In short: On March 20, 2025, FDA issued a Form 483 with 2 observations to Thermo Electron LED GmbH (FEI 3005737891) after an inspection that ran Mar 17 – Mar 20, 2025. The investigator was Stephen D. Eich. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.90(a) (1×) · 820.50 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Products that do not conform to specifications…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Stephen D. Eich
6 documents · 2019–2025
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Illinois.
The firmThermo Electron LED GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thermo Electron LED GmbH?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Thermo Electron LED GmbH?
Stephen D. Eich is named on this Form 483, for the inspection of Mar 17 – Mar 20, 2025. Each investigator has a profile showing what they cite most.
When was Thermo Electron LED GmbH inspected by FDA?
The inspection ran Mar 17 – Mar 20, 2025, and the Form 483 is dated March 20, 2025.
How do I get the full Form 483 for Thermo Electron LED GmbH?
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.