Cyalume Technologies, Inc
Form 483 issued October 19, 2022 · W Springfield, Massachusetts
- Inspection
- Oct 12 – Oct 19, 2022
- Investigator
- Jeffrey J. Thibodeau
- Observations
- 2
- Pages
- 4
- FEI number
- 1000137551
In short: On October 19, 2022, FDA issued a Form 483 with 2 observations to Cyalume Technologies, Inc in W Springfield, Massachusetts (FEI 1000137551) after an inspection that ran Oct 12 – Oct 19, 2022. The investigator was Jeffrey J. Thibodeau. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 2 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(i) (1×) · 820.30(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design change…
- 02
Procedures for design output…
This inspection in context
Jeffrey J. Thibodeau
7 documents · 2015–2024
Cites 820.70(b) (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCyalume 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 820.30(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cyalume Technologies, Inc?
FDA listed 2 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Cyalume Technologies, Inc?
Jeffrey J. Thibodeau is named on this Form 483, for the inspection of Oct 12 – Oct 19, 2022. Each investigator has a profile showing what they cite most.
When was Cyalume Technologies, Inc inspected by FDA?
The inspection ran Oct 12 – Oct 19, 2022, and the Form 483 is dated October 19, 2022.
How do I get the full Form 483 for Cyalume Technologies, Inc?
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