Pharmasept Medical Products 1995 Ltd. FDA Record
- Latest inspection OAI · Jun 22, 2023
- No warning letters matched by name
Pharmasept Medical Products 1995 Ltd. has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Pharmasept Medical Products 1995 Ltd." is on file.
- Latest inspection
- Jun 22, 2023 · OAI
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 | 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 |
|---|---|---|---|---|
| Jun 22, 2023 | Caesarea, Israel | Devices | Official Action Indicated (OAI) | 3003623887 |
- 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 3003623887 | Caesarea, Israel | 1 | Jun 22, 2023 |
Pharmasept Medical Products 1995 Ltd. and the FDA: common questions
Has Pharmasept Medical Products 1995 Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Pharmasept Medical Products 1995 Ltd." 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 Pharmasept Medical Products 1995 Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Pharmasept Medical Products 1995 Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Pharmasept Medical Products 1995 Ltd.?
The most recent FDA inspection on file ended Jun 22, 2023 at Caesarea, Israel and was classified OAI. FDA has 1 inspection of Pharmasept Medical Products 1995 Ltd. on file, 1 of them classified OAI (official action indicated).
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