# FDA 483 - GenIbet Biopharmaceuticals, S.A. - Unknown Date

Source: https://www.keypedia.com/records/483/genibet-biopharmaceuticals-sa/eaf6a5e6-7b22-4e2c-a385-4efa0a572196

> FDA 483 for GenIbet Biopharmaceuticals, S.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GenIbet Biopharmaceuticals, S.A.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Genibet Biopharmaceuticals SA in Oeiras, Portugal, identified significant deficiencies across multiple areas of their drug manufacturing operations. The firm lacks adequate written procedures and supporting data for production and process controls, raising concerns about product quality and purity. Additionally, critical issues were noted with equipment cleaning processes and decontamination procedures, indicating a risk of cross-contamination.

## Related Documents

- [483 - 2025-01-21](https://www.keypedia.com/records/483/genibet-biopharmaceuticals-sa/ec4a036c-ca34-4856-8a9d-42d9f136637f)
- [483 - 2025-01-21](https://www.keypedia.com/records/483/genibet-biopharmaceuticals-sa/bae8b4d8-e80c-4f74-b3f3-60143f53510b)

## Related Officers

- [Miriam Ngundi, Consumer Safety Officer](https://www.keypedia.com/people/miriam-ngundi-consumer-safety-officer/36138dfb-06ec-4240-924f-6e5134925709)
- [investigator](https://www.keypedia.com/people/kathleen-r-jones/3760ffcd-ce90-4b7c-b0a6-726edc8264d8)
- [Umee Raniga, Consumer Safety Officer](https://www.keypedia.com/people/umee-raniga-consumer-safety-officer/5f0050c0-ac99-4206-b1ed-5f438df714a1)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd