# FDA 483 - GenIbet Biopharmaceuticals SA - Unknown Date

Source: https://www.keypedia.com/records/483/genibet-biopharmaceuticals-sa/17ebd92c-ffee-442e-9fe8-9cad86b9f1c9

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

---

## Details

- Record Type: 483
- Company Name: GenIbet Biopharmaceuticals SA
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of GenIbet Biopharmaceuticals SA, a drug substance/drug product manufacturer in Oeiras, Portugal, revealed significant deficiencies in production and process controls, equipment cleaning, and decontamination procedures. The firm lacked adequate written procedures and supporting data for manufacturing processes, failed to validate cleaning processes effectively, and did not adequately demonstrate decontamination to prevent cross-contamination. These issues indicate a lack of control over critical manufacturing operations.

## Related Officers

- [Kathleen R. Jones, Ph.D., Microbiologist](https://www.keypedia.com/people/kathleen-r-jones-phd-microbiologist/99407232-210a-4a1b-a295-0d3e88fab80c)
- [Umee Raniga, Consumer Safety Officer](https://www.keypedia.com/people/umee-raniga-consumer-safety-officer/5f0050c0-ac99-4206-b1ed-5f438df714a1)
- [Miriam Ngundi, Consumer Safety Officer](https://www.keypedia.com/people/miriam-ngundi-consumer-safety-officer/36138dfb-06ec-4240-924f-6e5134925709)

Company: https://www.keypedia.com/companies/genibet-biopharmaceuticals-sa/e00cba2f-32ab-442f-8e98-70f38b13ca33

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4