Total Thermal Imaging, Inc

FDA inspection history in La Mesa, California, 2018 to 2019

1
Warning letter
1
Form 483

Every document, by year

  • Warning letter
  • Form 483

2018: one Form 483; 2019: one warning letter.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2018–19One Form 483 and one warning letter, at La Mesa, California.

Cited most

Across all Total Thermal Imaging observations on file

The complete Total Thermal Imaging file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Also: one document not tied to a site.

Documents

2 on file, newest first
DateDocumentPrice
2019-02-22Warning letter Warning letter$99
2018-08-02483 Form 483$99

Investigators on these documents

Scott K. Zika (1)Shaquenta Y. Perkins (1)

FEI number 3013987098 · most recent document Feb 22, 2019

About Total Thermal Imaging, Inc

How many FDA Form 483s has Total Thermal Imaging, Inc received?

FDA Intel has 1 Form 483 on file for Total Thermal Imaging, Inc; the most recent is dated Aug 2, 2018.

When was Total Thermal Imaging, Inc last inspected by FDA?

The most recent FDA inspection document on file for Total Thermal Imaging, Inc is a Form 483 dated Aug 2, 2018, for the site in La Mesa, California.

What did FDA cite at Total Thermal Imaging, Inc?

The regulations cited most in the observations on file for Total Thermal Imaging, Inc are 21 CFR 820.20 (Management responsibility), 2 times; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100 (Corrective and preventive action), 1 time.

Has Total Thermal Imaging, Inc received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Total Thermal Imaging, Inc; the most recent is dated Feb 22, 2019.