CoreTex Products Inc.
FDA inspection history in Erwin, Tennessee, 2021
- 1
- Form 483
Every document, by year
- Form 483
2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Erwin, Tennessee.
Cited most
Across all CoreTex Products observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.125(a)Labeling issuance1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete CoreTex Products file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Erwin, Tennessee
One Form 483 · 2021 · 3 observations
Latest: Form 483, Apr 28, 2021 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-04-28 | 483 Form 483 | Erwin, Tennessee | 3 | $99 |
Investigators on these documents
FEI number 3002719565 · most recent document Apr 28, 2021
About CoreTex Products Inc.
How many FDA Form 483s has CoreTex Products Inc. received?
FDA Intel has 1 Form 483 on file for CoreTex Products Inc.; the most recent is dated Apr 28, 2021.
When was CoreTex Products Inc. last inspected by FDA?
The most recent FDA inspection document on file for CoreTex Products Inc. is a Form 483 dated Apr 28, 2021, for the site in Erwin, Tennessee.
What did FDA cite at CoreTex Products Inc.?
The regulations cited most in the observations on file for CoreTex Products Inc. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.125(a) (Labeling issuance), 1 time; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 1 time.