RSH Medical LLC FDA Record
RSH Medical LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "RSH Medical LLC" is on file.
- Latest inspection
- Mar 27, 2025 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | 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 27, 2025 | Honolulu, HI | Biologics | No Action Indicated (NAI) | 3003968980 |
| May 19, 2010 | Honolulu, HI | Biologics | No Action Indicated (NAI) | 3003968980 |
- 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 3003968980 | Honolulu, HI | 2 | Mar 27, 2025 |
RSH Medical LLC and the FDA: common questions
Has RSH Medical LLC received an FDA warning letter?
No FDA warning letter addressed to the name "RSH Medical LLC" 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 RSH Medical LLC received an FDA Form 483?
FDA has not published a Form 483 for "RSH Medical LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect RSH Medical LLC?
The most recent FDA inspection on file ended Mar 27, 2025 at Honolulu, HI and was classified NAI. FDA has 2 inspections of RSH Medical LLC on file.
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