# FDA 483 - IOI OLEO GMBH - January 17, 2020

Source: https://www.globalkeysolutions.net/records/483/ioi-oleo-gmbh/9eeb8f5e-4e7c-4824-8e2b-17d992f4c5ff

> FDA 483 for IOI OLEO GMBH on January 17, 2020. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: IOI OLEO GMBH
- Inspection Date: 2020-01-17
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: IOI OLEO GMBH, a drug substances manufacturer in Witten, Germany, was inspected and cited for significant deficiencies across multiple areas. Observations included inadequate complaint investigations, failure to calibrate manufacturing equipment, improper identification and control of drug substance containers and raw materials, and an incomplete employee training program. These issues indicate a lack of robust quality control and adherence to good manufacturing practices.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/junho-pak/4abe53fb-ad20-490d-9e71-6216a9f863f5)

Company: https://www.globalkeysolutions.net/companies/ioi-oleo-gmbh/76de4547-287b-433f-a620-69b70610edd4

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1