Lujena, Inc
FDA inspection history in El Cajon, California, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at El Cajon, California.
Cited most
Across all Lujena observations on file
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30(g)Design controls1
The complete Lujena file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
El Cajon, California
One Form 483 · 2024 · 7 observations
Latest: Form 483, Nov 19, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-19 | 483 Form 483 | El Cajon, California | 7 | $99 |
Investigators on these documents
FEI number 3029582858 · most recent document Nov 19, 2024
About Lujena, Inc
How many FDA Form 483s has Lujena, Inc received?
FDA Intel has 1 Form 483 on file for Lujena, Inc; the most recent is dated Nov 19, 2024.
When was Lujena, Inc last inspected by FDA?
The most recent FDA inspection document on file for Lujena, Inc is a Form 483 dated Nov 19, 2024, for the site in El Cajon, California.
What did FDA cite at Lujena, Inc?
The regulations cited most in the observations on file for Lujena, Inc are 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.20(c) (Management responsibility), 1 time.