C-Axis PR., Inc
Form 483 issued October 24, 2024 · Caguas, Puerto Rico
- Inspection
- Oct 21 – Oct 24, 2024
- Investigator
- Nydia E. Colon
- Observations
- 2
- Pages
- 4
- FEI number
- 3005029036
In short: On October 24, 2024, FDA issued a Form 483 with 2 observations to C-Axis PR., Inc in Caguas, Puerto Rico (FEI 3005029036) after an inspection that ran Oct 21 – Oct 24, 2024. The investigator was Nydia E. Colon. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
Production & process controls and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.80(b) (1×) · 820.25(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for acceptance of incoming product have…
- 02
Procedures for training and identifying training needs have…
This inspection in context
Nydia E. Colon
4 documents · 2019–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmC-Axis PR., Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C-Axis PR., Inc?
FDA listed 2 observations on this Form 483, mostly about production & process controls and management 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 C-Axis PR., Inc?
Nydia E. Colon is named on this Form 483, for the inspection of Oct 21 – Oct 24, 2024. Each investigator has a profile showing what they cite most.
When was C-Axis PR., Inc inspected by FDA?
The inspection ran Oct 21 – Oct 24, 2024, and the Form 483 is dated October 24, 2024.
How do I get the full Form 483 for C-Axis PR., Inc?
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