Nortec Quimica SA
FDA inspection history in Duque de Caxias, Brazil, 2022
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2022: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One warning letter and one Form 483, at Duque de Caxias, Brazil.
Cited most
Across all Nortec Quimica observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Nortec Quimica file.
All 3 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
Duque de Caxias, Brazil
One warning letter, one Form 483 and one close-out letter · 2022 · 3 observations
Latest: Warning letter, Dec 8, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-12-08 | Warning letter Warning letter | Duque de Caxias, Brazil | — | $99 |
| 2022-07-22 | 483 Form 483 | Duque de Caxias, Brazil | 3 | $99 |
| Undated | Close-out Close-out letter | Duque de Caxias, Brazil | — | $99 |
FEI number 3007616930 · most recent document Dec 8, 2022
About Nortec Quimica SA
How many FDA Form 483s has Nortec Quimica SA received?
FDA Intel has 1 Form 483 on file for Nortec Quimica SA; the most recent is dated Jul 22, 2022.
When was Nortec Quimica SA last inspected by FDA?
The most recent FDA inspection document on file for Nortec Quimica SA is a Form 483 dated Jul 22, 2022, for the site in Duque de Caxias, Brazil.
What did FDA cite at Nortec Quimica SA?
The regulations cited most in the observations on file for Nortec Quimica SA are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.
Has Nortec Quimica SA received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Nortec Quimica SA; the most recent is dated Dec 8, 2022.