Nortec Quimica SA
Form 483 issued July 22, 2022 · Duque de Caxias, Brazil
- Observations
- 3
- Pages
- 2
- FEI number
- 3007616930
In short: On July 22, 2022, FDA issued a Form 483 with 3 observations to Nortec Quimica SA in Duque de Caxias, Rio de Janeiro (FEI 3007616930). Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The main responsibilities of the independent quality unit(s) should not be delegated. These responsibilities should be…
- 02
Computerized systems should have sufficient controls to prevent unauthorized access or changes to data. There should…
- 03
If system breakdowns or failures would result in the permanent loss of records, a back-up system…
This inspection in context
Questions about this 483
What did FDA find at Nortec Quimica SA?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Nortec Quimica SA inspected by FDA?
This Form 483 is dated July 22, 2022.
How do I get the full Form 483 for Nortec Quimica SA?
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