# FDA 483 - Croda Iberica SA - August 05, 2019

Source: https://www.keypedia.com/records/483/croda-iberica-sa/2b9113e9-d85a-45bd-9e48-b5389a65402f

> FDA 483 for Croda Iberica SA on August 05, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Croda Iberica SA
- Inspection Date: 2019-08-05
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: An FDA inspection of Croda Iberica SA, an API manufacturer in Fogars de la Selva, Barcelona, Spain, revealed significant deficiencies in their quality systems. Observations included improper storage of stability samples, multiple failures in quality unit responsibilities, and inadequate employee training practices. These issues collectively indicate a lack of adherence to current Good Manufacturing Practices.

## Related Officers

- [Investigator](https://www.keypedia.com/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.keypedia.com/companies/croda-iberica-sa/d109dc60-2a6b-4293-8c01-1761b3a649f2

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