HF Acquisition Co LLC
FDA Regulatory Profile
HF Acquisition Co LLC has 10 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2332-2026 · Class II · Apr 13, 2026
- Latest inspection
- Jun 26, 2025 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 10 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 9 | Nov 11, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2332-2026 | Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE… | Apr 13, 2026 |
| Z-2331-2026 | Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE… | Apr 13, 2026 |
| Z-1141-2025 | Class II | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12… | Dec 11, 2024 |
| D-0870-2023 | Class III | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo… | Jun 6, 2023 |
| D-1392-2020 | Class III | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use Only… | Jun 17, 2020 |
| Z-2779-2020 | Class II | STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians… | Jun 5, 2020 |
| Z-2791-2020 | Class II | STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include… | Jun 4, 2020 |
| Z-2789-2020 | Class II | STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include… | Jun 4, 2020 |
| Z-2788-2020 | Class II | HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC… | Jun 4, 2020 |
| Z-2790-2020 | Class II | STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan… | Jun 4, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jun 26, 2025 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
| Oct 10, 2019 | Mukilteo, WA | Drugs | No Action Indicated (NAI) | 3014534 |
| Feb 9, 2018 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
| Nov 5, 2014 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
| Oct 29, 2013 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
| Oct 13, 2011 | Mukilteo, WA | Drugs | No Action Indicated (NAI) | 3014534 |
| Nov 30, 2010 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
| Jan 19, 2010 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
| Dec 10, 2008 | Mukilteo, WA | Drugs | Voluntary Action Indicated (VAI) | 3014534 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3014534 | Mukilteo, WA | 9 | Jun 26, 2025 |