# FDA 483 - ESTABLISHMENT LABS SA - July 24, 2024

Source: https://www.keypedia.com/records/483/establishment-labs-sa/a018f730-82d7-4eaa-a6ff-b66928434b42

> FDA 483 for ESTABLISHMENT LABS SA on July 24, 2024. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: ESTABLISHMENT LABS SA
- Inspection Date: 2024-07-24
- Product Type: other
- Office Name: Office of the Commissioner
- Summary: I am unable to provide a summary as the provided document content explicitly states "Extraction failed: The provided file could not be processed. All PDF extraction methods failed. Last OCR error: Tesseract process timeout." Without the content of the FDA 483 document, I cannot identify the company name, inspection dates, main violations, regulatory framework, or required actions to generate the requested summary.

## Related Documents

- [483 - 2024-07-26](https://www.keypedia.com/records/483/establishment-labs-sa/ce76af9e-7eca-45ee-8507-6671bb789c1a)
- [483 - 2024-07-26](https://www.keypedia.com/records/483/establishment-labs-sa/ae564e8a-4879-407a-ad94-d96fc84d76fb)

## Related Officers

- [FDA_PERSONNEL](https://www.keypedia.com/people/extraction-failed/f8d11a9b-3d86-47a8-a6cb-2c939dae9ea6)

Company: https://www.keypedia.com/companies/establishment-labs-sa/d4fef84a-8952-4b22-b443-5b6c14d4b4d2

Office: https://www.keypedia.com/offices/office-of-the-commissioner/79483979-9582-427f-ac3d-46c715811424