# FDA 483 - Norbitec GmbH - April 06, 2023

Source: https://www.keypedia.com/records/483/norbitec-gmbh/75bf548d-c8ac-4320-bb57-7ec51da04eb8

> FDA 483 for Norbitec GmbH on April 06, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Norbitec GmbH
- Inspection Date: 2023-04-06
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Norbitec GmbH, a drug substance manufacturer in Uetersen, Germany, received four observations during an FDA inspection. The observations detail significant deficiencies in quality oversight, cleaning procedures, validation activities for manufacturing processes and equipment, and the maintenance of facility systems. These issues collectively indicate a lack of control over critical aspects of drug substance production.

## Related Officers

- [Nailing Zhang](https://www.keypedia.com/people/nailing-zhang/d3814d08-b799-4de1-b901-1b90da0e0178)
- [Senior Regulatory Specialist](https://www.keypedia.com/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.keypedia.com/companies/norbitec-gmbh/7a35a1cf-8ea9-4c18-b357-c7a5530fcd2b

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