Blue Elephant Inc
FDA inspection history in Southlake, Texas, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Southlake, Texas.
Cited most
Across all Blue Elephant observations on file
- 21 CFR 820.30(b)Design controls6
- 21 CFR 8202
- 21 CFR 820.181Device master record1
- 21 CFR 820.25(b)Personnel1
- 21 CFR 820.50(a)(3)Purchasing controls1
The complete Blue Elephant file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Southlake, Texas
One Form 483 · 2025 · 9 observations
Latest: Form 483, May 16, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-16 | 483 Form 483 | Southlake, Texas | 9 | $99 |
Investigators on these documents
FEI number 3031025053 · most recent document May 16, 2025
About Blue Elephant Inc
How many FDA Form 483s has Blue Elephant Inc received?
FDA Intel has 1 Form 483 on file for Blue Elephant Inc; the most recent is dated May 16, 2025.
When was Blue Elephant Inc last inspected by FDA?
The most recent FDA inspection document on file for Blue Elephant Inc is a Form 483 dated May 16, 2025, for the site in Southlake, Texas.
What did FDA cite at Blue Elephant Inc?
The regulations cited most in the observations on file for Blue Elephant Inc are 21 CFR 820.30(b) (Design controls), 6 times; 21 CFR 820, 2 times; 21 CFR 820.181 (Device master record), 1 time.