FDA inspection
Organo Sintesis, S.A. De C.V.: FDA inspection ending Jul 28, 2023
FDA inspection 1218259 · Voluntary Action Indicated (VAI) · Capulhuac
Key facts
| Inspection ID | 1218259 |
|---|---|
| Firm | Organo Sintesis, S.A. De C.V. |
| FEI number | 3000324304 |
| Address | Carretera Amomolulco a Santiago Tianguistenco Km 10.8, Aguablanca |
| City | Capulhuac |
| Country | Mexico |
| Fiscal year | 2023 |
| Inspection end date | Jul 28, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No 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