Lujena, Inc
Form 483 issued November 19, 2024 · El Cajon, California
- Inspection
- Nov 12 – Nov 19, 2024
- Investigators
- Date Syrett· Juanj Wu
- Observations
- 7
- Pages
- 5
- FEI number
- 3029582858
In short: On November 19, 2024, FDA issued a Form 483 with 7 observations to Lujena, Inc in El Cajon, California (FEI 3029582858) after an inspection that ran Nov 12 – Nov 19, 2024. The investigators were Date Syrett and Juanj Wu. Most observations concern management controls and design controls.
At a glance
Observations span 4 systems, led by management controls.
What FDA observed
Preview: the opening words of each observation- 01
Results of the design risk analysis…
- 02
Procedures for device history records have…
- 03
Records of acceptable suppliers, contractors and consultants have…
- 04
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
This inspection in context
Date Syrett
1 document · 2024
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in California.
The firmLujena, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lujena, Inc?
FDA listed 7 observations on this Form 483, mostly about management controls, design controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Lujena, Inc?
Date Syrett and Juanj Wu are named on this Form 483, for the inspection of Nov 12 – Nov 19, 2024. Each investigator has a profile showing what they cite most.
When was Lujena, Inc inspected by FDA?
The inspection ran Nov 12 – Nov 19, 2024, and the Form 483 is dated November 19, 2024.
How do I get the full Form 483 for Lujena, 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.