Total Thermal Imaging, Inc
Form 483 issued August 2, 2018 · La Mesa, California
- Inspection
- Jul 3 – Aug 2, 2018
- Investigators
- Scott K. Zika· Shaquenta Y. Perkins
- Observations
- 10
- Pages
- 7
- FEI number
- 3013987098
In short: On August 2, 2018, FDA issued a Form 483 with 10 observations to Total Thermal Imaging, Inc in La Mesa, California (FEI 3013987098) after an inspection that ran Jul 3 – Aug 2, 2018. The investigators were Scott K. Zika and Shaquenta Y. Perkins. Most observations concern management controls and cAPA; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
Management controls and capa account for 7 of 10 observations.
Most cited: 21 CFR 820.20 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design control…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for acceptance activities…
- 04
Procedures for corrective and preventive action…
This inspection in context
Scott K. Zika
7 documents · 2009–2018
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in California.
The firmTotal Thermal Imaging, Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.20
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Total Thermal Imaging, Inc?
FDA listed 10 observations on this Form 483, mostly about management controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
Who inspected Total Thermal Imaging, Inc?
Scott K. Zika and Shaquenta Y. Perkins are named on this Form 483, for the inspection of Jul 3 – Aug 2, 2018. Each investigator has a profile showing what they cite most.
When was Total Thermal Imaging, Inc inspected by FDA?
The inspection ran Jul 3 – Aug 2, 2018, and the Form 483 is dated August 2, 2018.
How do I get the full Form 483 for Total Thermal Imaging, 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.