American Thermal Instruments Inc
Form 483 issued March 14, 2022 · Dayton, Ohio
- Inspection
- Feb 23 – Mar 14, 2022
- Investigator
- Javonica F. Penn
- Observations
- 6
- Pages
- 6
- FEI number
- 1526410
In short: On March 14, 2022, FDA issued a Form 483 with 6 observations to American Thermal Instruments Inc in Dayton, Ohio (FEI 1526410) after an inspection that ran Feb 23 – Mar 14, 2022. The investigator was Javonica F. Penn. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for design input…
- 03
Production processes were not monitored to ensure that a device conforms…
- 04
Procedures for device history records…
This inspection in context
Javonica F. Penn
4 documents · 2016–2026
Cites ISO 13485:2016 Clause 7.4.1 more than any other section. Most of their documents are for sites in Ohio.
The firmAmerican Thermal Instruments Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at American Thermal Instruments Inc?
FDA listed 6 observations on this Form 483, mostly about production & process controls, design controls and records & documents. The opening words of each observation are shown on this page.
Who inspected American Thermal Instruments Inc?
Javonica F. Penn is named on this Form 483, for the inspection of Feb 23 – Mar 14, 2022. Each investigator has a profile showing what they cite most.
When was American Thermal Instruments Inc inspected by FDA?
The inspection ran Feb 23 – Mar 14, 2022, and the Form 483 is dated March 14, 2022.
How do I get the full Form 483 for American Thermal Instruments Inc?
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.