NTP RADIOISOTOPES
Form 483 issued April 11, 2025 · BRITS, South Africa
- Inspection
- Apr 7 – Apr 11, 2025
- Investigator
- Lori M. Newman
- Observations
- 4
- Pages
- 4
- FEI number
- 3002806423
In short: On April 11, 2025, FDA issued a Form 483 with 4 observations to NTP RADIOISOTOPES in BRITS, North West (FEI 3002806423) after an inspection that ran Apr 7 – Apr 11, 2025. The investigator was Lori M. Newman. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to adequately investigate all critical deviations and extend investigations to other batches that may have…
- 02
Failure to establish adequate timelines for closures of…
- 03
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your…
- 04
Failure to establish and document specifications for raw materials…
This inspection in context
Lori M. Newman
18 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmNTP RADIOISOTOPES history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NTP RADIOISOTOPES?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected NTP RADIOISOTOPES?
Lori M. Newman is named on this Form 483, for the inspection of Apr 7 – Apr 11, 2025. Each investigator has a profile showing what they cite most.
When was NTP RADIOISOTOPES inspected by FDA?
The inspection ran Apr 7 – Apr 11, 2025, and the Form 483 is dated April 11, 2025.
How do I get the full Form 483 for NTP RADIOISOTOPES?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.