ASEPTIKITS, LLC
Form 483 issued December 3, 2025 · North Salt Lake, Utah
- Inspection
- Nov 11 – Dec 3, 2025
- Investigators
- James R. Montero· Monica L. Gutierrez
- Observations
- 7
- Pages
- 7
- FEI number
- 3015422213
In short: On December 3, 2025, FDA issued a Form 483 with 7 observations to ASEPTIKITS, LLC in North Salt Lake, Utah (FEI 3015422213) after an inspection that ran Nov 11 – Dec 3, 2025. The investigators were James R. Montero and Monica L. Gutierrez. Most observations concern production & process controls and management controls.
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design control…
- 02
A device master record has…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
Procedures for finished device acceptance…
This inspection in context
James R. Montero
10 documents · 2014–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmASEPTIKITS, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ASEPTIKITS, LLC?
FDA listed 7 observations on this Form 483, mostly about production & process controls, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected ASEPTIKITS, LLC?
James R. Montero and Monica L. Gutierrez are named on this Form 483, for the inspection of Nov 11 – Dec 3, 2025. Each investigator has a profile showing what they cite most.
When was ASEPTIKITS, LLC inspected by FDA?
The inspection ran Nov 11 – Dec 3, 2025, and the Form 483 is dated December 3, 2025.
How do I get the full Form 483 for ASEPTIKITS, LLC?
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.