ASEPTIKITS, LLC
FDA inspection history in North Salt Lake, Utah, 2025 to 2026
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2025: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2025–26One Form 483 and one warning letter, at North Salt Lake, Utah.
Cited most
Across all ASEPTIKITS observations on file
- 21 CFR 820.181Device master record1
- 21 CFR 820.20Management responsibility1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.30Design controls1
- 21 CFR 820.50Purchasing controls1
The complete ASEPTIKITS file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
North Salt Lake, Utah
One warning letter and one Form 483 · 2025 to 2026 · 7 observations
Latest: Warning letter, Jun 4, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-06-04 | Warning letter Warning letter | North Salt Lake, Utah | — | $99 |
| 2025-12-03 | 483 Form 483 | North Salt Lake, Utah | 7 | $99 |
Investigators on these documents
FEI number 3015422213 · most recent document Jun 4, 2026
About ASEPTIKITS, LLC
How many FDA Form 483s has ASEPTIKITS, LLC received?
FDA Intel has 1 Form 483 on file for ASEPTIKITS, LLC; the most recent is dated Dec 3, 2025.
When was ASEPTIKITS, LLC last inspected by FDA?
The most recent FDA inspection document on file for ASEPTIKITS, LLC is a Form 483 dated Dec 3, 2025, for the site in North Salt Lake, Utah.
What did FDA cite at ASEPTIKITS, LLC?
The regulations cited most in the observations on file for ASEPTIKITS, LLC are 21 CFR 820.181 (Device master record), 1 time; 21 CFR 820.20 (Management responsibility), 1 time; 21 CFR 820.22 (Quality audit), 1 time.
Has ASEPTIKITS, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for ASEPTIKITS, LLC; the most recent is dated Jun 4, 2026.