Cyalume Technologies, Inc
Form 483 issued August 24, 2018 · W Springfield, Massachusetts
- Inspection
- Aug 23 – Aug 24, 2018
- Investigator
- Jeffrey J. Thibodeau
- Observations
- 1
- Pages
- 3
- FEI number
- 1000137551
In short: On August 24, 2018, FDA issued a Form 483 with 1 observation to Cyalume Technologies, Inc in W Springfield, Massachusetts (FEI 1000137551) after an inspection that ran Aug 23 – Aug 24, 2018. The investigator was Jeffrey J. Thibodeau. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
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 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cyalume Technologies, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.17 (what are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?). 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 Aug 23 – Aug 24, 2018. Each investigator has a profile showing what they cite most.
When was Cyalume Technologies, Inc inspected by FDA?
The inspection ran Aug 23 – Aug 24, 2018, and the Form 483 is dated August 24, 2018.
How do I get the full Form 483 for Cyalume Technologies, Inc?
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