# FDA 483 - Octapharma AB - September 19, 2023

Source: https://www.keypedia.com/records/483/octapharma-ab/39c0cc19-3c92-4f74-935f-51aa7ab303f4

> FDA 483 for Octapharma AB on September 19, 2023. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Octapharma AB
- Inspection Date: 2023-09-19
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Octapharma AB, a plasma derivatives manufacturer in Stockholm, Sweden, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately record and justify deviations from production and process control procedures, including a lack of documented training for updated instructions and corrective actions. Additionally, equipment was not maintained at appropriate intervals, and written procedures for in-process controls and handling of failed materials were not established or followed.

## Related Officers

- [Scott T. Ballard](https://www.keypedia.com/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)
- [Olga Simakova](https://www.keypedia.com/people/olga-simakova/2ee5985e-425e-4732-8869-2be861f5d792)
- [Ze Zeuj](https://www.keypedia.com/people/ze-zeuj/b4ca7158-e9ef-49da-aae5-d78b91e36b0f)
- [Nhan L Truong](https://www.keypedia.com/people/nhan-l-truong/cca10526-f9c4-413f-b80e-ed09a2678117)

Company: https://www.keypedia.com/companies/octapharma-ab/5a456872-4ca6-4418-b006-6e7e219ec262

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321