# FDA 483 - Advanced Accelerator Applications (Italy) srl - September 03, 2019

Source: https://www.keypedia.com/records/483/advanced-accelerator-applications-italy-srl/4e05f87d-a1ed-4ebe-a638-8a0a7c8fe09c

> FDA 483 for Advanced Accelerator Applications (Italy) srl on September 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Accelerator Applications (Italy) srl
- Inspection Date: 2019-09-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: This FDA Form 483 was issued to Advanced Accelerator Applications in Colleretto Giacosa, Italy, following an inspection of their PET and sterile drug product manufacturing facility. The inspection revealed significant deficiencies in aseptic processing, environmental monitoring, container handling, adherence to visual inspection procedures, and laboratory controls. These issues indicate a moderate to severe risk of product contamination and quality control failures.

## Related Officers

- [Jose A. Cruz Gonzalez](https://www.keypedia.com/people/jose-a-cruz-gonzalez/a005cff1-0a90-4396-82c4-de4b0a579374)

Company: https://www.keypedia.com/companies/advanced-accelerator-applications-italy-srl/09ac059c-6735-4082-8674-a88476dbdbc6

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