Cyalume Specialty Products Inc
Form 483 issued October 3, 2022 · Bound Brook, New Jersey
- Inspection
- Aug 26 – Oct 3, 2022
- Investigators
- Frederick Razzaghi· Jay B. Shah
- Observations
- 3
- Pages
- 2
- FEI number
- 2243955
In short: On October 3, 2022, FDA issued a Form 483 with 3 observations to Cyalume Specialty Products Inc in Bound Brook, New Jersey (FEI 2243955) after an inspection that ran Aug 26 – Oct 3, 2022. The investigators were Frederick Razzaghi and Jay B. Shah. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.22 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no effective quality agreement between your…
- 02
You have not conducted temperature and humidity…
- 03
There is no written procedure that delineated the labeling of…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmCyalume Specialty Products Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cyalume Specialty Products Inc?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cyalume Specialty Products Inc?
Frederick Razzaghi and Jay B. Shah are named on this Form 483, for the inspection of Aug 26 – Oct 3, 2022. Each investigator has a profile showing what they cite most.
When was Cyalume Specialty Products Inc inspected by FDA?
The inspection ran Aug 26 – Oct 3, 2022, and the Form 483 is dated October 3, 2022.
How do I get the full Form 483 for Cyalume Specialty Products 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.