Tristel Solutions Limited
Form 483 issued February 13, 2025
- Inspection
- Feb 10 – Feb 13, 2025
- Investigator
- Melanie W. Pishnery
- Observations
- 3
- Pages
- 4
- FEI number
- 3006892175
In short: On February 13, 2025, FDA issued a Form 483 with 3 observations to Tristel Solutions Limited (FEI 3006892175) after an inspection that ran Feb 10 – Feb 13, 2025. The investigator was Melanie W. Pishnery. Most observations concern cAPA and design controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Products that do not conform to specifications…
- 03
The results of design validation, including method(s), were not documented in…
This inspection in context
Melanie W. Pishnery
4 documents · 2022–2025
Cites 211.42(c)(10) (design and construction features) more than any other section. Most of their documents are for sites in Japan.
The firmTristel Solutions Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Tristel Solutions Limited?
FDA listed 3 observations on this Form 483, mostly about cAPA and design controls. The opening words of each observation are shown on this page.
Who inspected Tristel Solutions Limited?
Melanie W. Pishnery is named on this Form 483, for the inspection of Feb 10 – Feb 13, 2025. Each investigator has a profile showing what they cite most.
When was Tristel Solutions Limited inspected by FDA?
The inspection ran Feb 10 – Feb 13, 2025, and the Form 483 is dated February 13, 2025.
How do I get the full Form 483 for Tristel Solutions Limited?
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.