Thermedx LLC
FDA inspection history in Solon, Ohio, 2015 to 2016
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one warning letter; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16One warning letter and one Form 483, at Solon, Ohio.
Cited most
Across all Thermedx observations on file
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.75Process validation1
- 21 CFR 820.90Nonconforming product1
The complete Thermedx 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
Solon, Ohio
One Form 483 and one warning letter · 2015 to 2016 · 3 observations
Latest: Form 483, Jul 18, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-07-18 | 483 Form 483 | Solon, Ohio | 3 | $99 |
| 2015-04-08 | Warning letter Warning letter | Solon, Ohio | — | $99 |
Investigators on these documents
FEI number 3007495879 · most recent document Jul 18, 2016
About Thermedx LLC
How many FDA Form 483s has Thermedx LLC received?
FDA Intel has 1 Form 483 on file for Thermedx LLC; the most recent is dated Jul 18, 2016.
When was Thermedx LLC last inspected by FDA?
The most recent FDA inspection document on file for Thermedx LLC is a Form 483 dated Jul 18, 2016, for the site in Solon, Ohio.
What did FDA cite at Thermedx LLC?
The regulations cited most in the observations on file for Thermedx LLC are 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.75 (Process validation), 1 time; 21 CFR 820.90 (Nonconforming product), 1 time.
Has Thermedx LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Thermedx LLC; the most recent is dated Apr 8, 2015.