NucleusHealth, LLC
Form 483 issued October 30, 2019 · San Diego, California
- Inspection
- Oct 24 – Oct 30, 2019
- Investigator
- Jenny L. McCardell
- Observations
- 3
- Pages
- 4
- FEI number
- 3008008144
In short: On October 30, 2019, FDA issued a Form 483 with 3 observations to NucleusHealth, LLC in San Diego, California (FEI 3008008144) after an inspection that ran Oct 24 – Oct 30, 2019. The investigator was Jenny L. McCardell. Most observations concern design controls and records & documents.
At a glance
Design controls and records & documents account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design input have…
- 02
A device master record…
- 03
Procedures for training and identifying training needs have…
This inspection in context
Jenny L. McCardell
1 document · 2019
Cites 820.181 (device master record) more than any other section. Most of their documents are for sites in California.
The firmNucleusHealth, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NucleusHealth, LLC?
FDA listed 3 observations on this Form 483, mostly about design controls, records & documents and management controls. The opening words of each observation are shown on this page.
Who inspected NucleusHealth, LLC?
Jenny L. McCardell is named on this Form 483, for the inspection of Oct 24 – Oct 30, 2019. Each investigator has a profile showing what they cite most.
When was NucleusHealth, LLC inspected by FDA?
The inspection ran Oct 24 – Oct 30, 2019, and the Form 483 is dated October 30, 2019.
How do I get the full Form 483 for NucleusHealth, LLC?
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.