FDA inspection
ESTABLISHMENT LABS SA: FDA inspection ending Jul 26, 2024
FDA inspection 1245799 · Voluntary Action Indicated (VAI) · Alajuela
Key facts
| Inspection ID | 1245799 |
|---|---|
| Firm | ESTABLISHMENT LABS SA |
| FEI number | 3012883202 |
| Address | Coyol Free Zone & Business Park, Building B- 25 |
| City | Alajuela |
| Fiscal year | 2024 |
| Inspection end date | Jul 26, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: Devices|Postmarket Assurance: 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Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket 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Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices|Postmarket Assurance: Medical Devices|Product Evaluation: Medical Devices |
| Product type | Devices |
At a glance
- 1–9 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