Hospi Corporation FDA Record
Hospi Corporation has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Hospi Corporation" is on file.
- Latest inspection
- Mar 14, 2025 · VAI
- Latest 510(k)
- Jan 24, 2014
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | San Mateo, CA | Devices | Voluntary Action Indicated (VAI) | 3010761399 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010761399 | San Mateo, CA | 1 | Mar 14, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K133881 | MACY CATHETER | Jan 24, 2014 |
Hospi Corporation and the FDA: common questions
Has Hospi Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "Hospi Corporation" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Hospi Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Hospi Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hospi Corporation?
The most recent FDA inspection on file ended Mar 14, 2025 at San Mateo, CA and was classified VAI. FDA has 1 inspection of Hospi Corporation on file.
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