# FDA 483 - GenIbet Biopharmaceuticals, S.A. - January 21, 2025

Source: https://www.globalkeysolutions.net/records/483/genibet-biopharmaceuticals-sa/bae8b4d8-e80c-4f74-b3f3-60143f53510b

> FDA 483 for GenIbet Biopharmaceuticals, S.A. on January 21, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GenIbet Biopharmaceuticals, S.A.
- Inspection Date: 2025-01-21
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: GenIbet Biopharmaceuticals, S.A. in Oeiras, Lisbon, Portugal, a biological drug product manufacturer, was inspected by the FDA. The inspection revealed deficiencies in complaint handling procedures, specifically the failure to maintain written records for drug product complaints. Additionally, the firm lacked established written procedures for annual evaluations and reviews of all investigations conducted for drug products, particularly for VOWST®.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/genibet-biopharmaceuticals-sa/eaf6a5e6-7b22-4e2c-a385-4efa0a572196)
- [483 - 2025-01-21](https://www.globalkeysolutions.net/records/483/genibet-biopharmaceuticals-sa/ec4a036c-ca34-4856-8a9d-42d9f136637f)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Investigator](https://www.globalkeysolutions.net/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

Company: https://www.globalkeysolutions.net/companies/genibet-biopharmaceuticals-sa/0caa1843-f97a-4138-b02a-16af961df290

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8