# FDA 483 - Biofac A/S - September 23, 2022

Source: https://www.keypedia.com/records/483/biofac-as/8f4d63d9-21d1-49ca-8bc8-e3b7e0240b30

> FDA 483 for Biofac A/S on September 23, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biofac A/S
- Inspection Date: 2022-09-23
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Biofac A/S, a manufacturer in Kastrup Copenhagen, Denmark, was cited for significant deficiencies across its quality management system, laboratory controls, and equipment validation. The inspection revealed failures in performing required quality reviews, inadequate computer system controls, unscientific test procedures, and a lack of thorough investigation into discrepancies and out-of-specification results. Additionally, the firm used unvalidated equipment for manufacturing GMP products, indicating a broad breakdown in quality assurance.

## Related Officers

- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/biofac-as/ee7acce7-ca25-4bce-b513-93e8638b50f2

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