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.
- 2018–19One Form 483 and one warning letter, at La Mesa, California.
Cited most
Across all Total Thermal Imaging observations on file
- 21 CFR 820.20Management responsibility2
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.198Complaint files1
- 21 CFR 820.22Quality audit1
The complete Total Thermal Imaging file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
La Mesa, California
One Form 483 · 2018 · 10 observations
Latest: Form 483, Aug 2, 2018 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-22 | Warning letter Warning letter | — | — | $99 |
| 2018-08-02 | 483 Form 483 | La Mesa, California | 10 | $99 |
Investigators on these documents
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.