Thermedx LLC
Form 483 issued July 18, 2016 · Solon, Ohio
- Inspection
- Jul 18, 2016
- Investigator
- Benjamin Dastoli
- Observations
- 3
- Pages
- 3
- FEI number
- 3007495879
In short: On July 18, 2016, FDA issued a Form 483 with 3 observations to Thermedx LLC in Solon, Ohio (FEI 3007495879) after an inspection that ran Jul 18, 2016. The investigator was Benjamin Dastoli. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Products that do not conform to specifications…
- 03
Procedures for corrective and preventive action…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmThermedx LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Thermedx LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Thermedx LLC?
Benjamin Dastoli is named on this Form 483, for the inspection of Jul 18, 2016. Each investigator has a profile showing what they cite most.
When was Thermedx LLC inspected by FDA?
The inspection ran Jul 18, 2016, and the Form 483 is dated July 18, 2016.
How do I get the full Form 483 for Thermedx LLC?
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.