FDA inspection
Nortec Quimica SA: FDA inspection ending Jul 22, 2022
FDA inspection 1177434 · Official Action Indicated (OAI) · Duque De Caxias
Key facts
| Inspection ID | 1177434 |
|---|---|
| Firm | Nortec Quimica SA |
| FEI number | 3007616930 |
| Address | Rua Dezessete # 200, Dist. Ind. Duque De Caxias - Xerem |
| City | Duque De Caxias |
| Country | Brazil |
| Fiscal year | 2022 |
| Inspection end date | Jul 22, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 639894 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data