NTP Radioisotopes SOC Ltd. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

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.

What these totals cover: FDA records filed under the name "NTP Radioisotopes SOC Ltd." and its spelling variant "Ntp Radioisotopes Soc".

Latest inspection
Apr 11, 2025 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections4Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

NTP Radioisotopes SOC Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

NTP Radioisotopes SOC Ltd.: FDA inspections per year 2017: 0 inspections020172018: 0 inspections020182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 1 inspections120252026: 0 inspections02026
YearInspectionsOAIWarning lettersRecall recordsClass I
202600000
202510000
202400000
202300000
202200000
202100000
202000000
201910000
201800000
201700000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

4 inspections from Mar 4, 2011 to Apr 11, 2025.

DateSiteProductClassificationFEI
Apr 11, 2025Brits, South AfricaDrugsVoluntary Action Indicated (VAI)3002806423
Oct 25, 2019Brits, South AfricaDrugsVoluntary Action Indicated (VAI)3002806423
Oct 31, 2014Brits, South AfricaDrugsVoluntary Action Indicated (VAI)3002806423
Mar 4, 2011Brits, South AfricaDrugsVoluntary 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002806423Brits, South Africa4Apr 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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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.