Blue Elephant Inc
Form 483 issued May 16, 2025 · Southlake, Texas
- Inspection
- May 9 – May 16, 2025
- Investigator
- Elizabeth A. Krolczyk
- Observations
- 9
- Pages
- 8
- FEI number
- 3031025053
In short: On May 16, 2025, FDA issued a Form 483 with 9 observations to Blue Elephant Inc in Southlake, Texas (FEI 3031025053) after an inspection that ran May 9 – May 16, 2025. The investigator was Elizabeth A. Krolczyk. Most observations concern design controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
6 of 9 observations on this 483 concern design controls.
Most cited: 21 CFR 820 (2×)
What FDA observed
Preview: the opening words of each observation- 0121 CFR 820.30(j)21 CFR 820
Observation 1: scanned text, readable in the full document.
- 02
A device master record…
- 03
Design plans that describe or reference the design and development activities and define responsibility for implementation…
- 0421 CFR 820.30(c)21 CFR 820
Design input requirements were…
This inspection in context
Elizabeth A. Krolczyk
6 documents · 2024–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmBlue Elephant Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(j)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Blue Elephant Inc?
FDA listed 9 observations on this Form 483, mostly about design controls, records & documents and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Blue Elephant Inc?
Elizabeth A. Krolczyk is named on this Form 483, for the inspection of May 9 – May 16, 2025. Each investigator has a profile showing what they cite most.
When was Blue Elephant Inc inspected by FDA?
The inspection ran May 9 – May 16, 2025, and the Form 483 is dated May 16, 2025.
How do I get the full Form 483 for Blue Elephant 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.