ASEPTIKITS, LLC
FDA establishment 3015422213, North Salt Lake, Utah, United States. Part of AseptiKits, LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
North Salt Lake, Utah, United States. Part of - Inspections: 1
- Official action indicated: 1
- Last inspection ended: Dec 3, 2025
- Warning letters: 1
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
Most Cited at This Site
Inspections citing each reference
- 21 CFR 830.300(a): Devices subject to device identification GUDID data submission requirements.1
- 21 CFR 820.30(a): Design control - no procedures1
- 21 CFR 820.80(d): Lack of or inadequate final acceptance procedures1
- 21 CFR 820.181: DMR - not or inadequately maintained1
- 21 CFR 820.22: Quality Audit/Reaudit - conducted1
- 21 CFR 820.20(c): Management review - Lack of or inadequate procedures1
- 21 CFR 820.50: Purchasing controls, Lack of or inadequate procedures1
Inspections
1 inspections, newest first| Ended | Product and area | Citations | Classification |
|---|---|---|---|
| Dec 3, 2025 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 7 cited references
| Official Action Indicated (OAI) |
Warning Letters
Letters naming this establishment; each opens the letter- 510(k) requiredJun 4, 2026
Identifiers
- FEI number
- 3015422213
- FDA firm profile
- Data Dashboard
- Company
- AseptiKits, LLC
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters