NTP Radioisotopes SOC Ltd. FDA Record
NTP Radioisotopes SOC Ltd. has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "NTP Radioisotopes SOC Ltd." is on file.
- Latest inspection
- Apr 11, 2025 · VAI
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 | 4 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 11, 2025 | Brits, South Africa | Drugs | Voluntary Action Indicated (VAI) | 3002806423 |
| Oct 25, 2019 | Brits, South Africa | Drugs | Voluntary Action Indicated (VAI) | 3002806423 |
| Oct 31, 2014 | Brits, South Africa | Drugs | Voluntary Action Indicated (VAI) | 3002806423 |
| Mar 4, 2011 | Brits, South Africa | Drugs | Voluntary Action Indicated (VAI) | 3002806423 |
- 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 3002806423 | Brits, South Africa | 4 | Apr 11, 2025 |
NTP Radioisotopes SOC Ltd. and the FDA: common questions
Has NTP Radioisotopes SOC Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "NTP Radioisotopes SOC 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 NTP Radioisotopes SOC Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "NTP Radioisotopes SOC Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect NTP Radioisotopes SOC Ltd.?
The most recent FDA inspection on file ended Apr 11, 2025 at Brits, South Africa and was classified VAI. FDA has 4 inspections of NTP Radioisotopes SOC Ltd. on file.
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