# FDA 483 - Advanced Accelerator Applications USA, Inc. - June 27, 2024

Source: https://www.keypedia.com/records/483/advanced-accelerator-applications-usa-inc/8a5d9f11-f3c3-423f-a0f4-9a9174e1f938

> FDA 483 for Advanced Accelerator Applications USA, Inc. on June 27, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advanced Accelerator Applications USA, Inc.
- Inspection Date: 2024-06-27
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Advanced Accelerator Applications USA, Inc. in Millburn, NJ, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations include failures in qualifying component suppliers, incomplete laboratory records for reference standards, and critical lapses in procedures to prevent microbiological contamination of sterile drug products. These issues indicate a lack of adequate controls over critical manufacturing processes and quality assurance.

## Related Documents

- [EIR - 2020-08-18](https://www.keypedia.com/records/eir/advanced-accelerator-applications-usa-inc/8766918a-8ced-4675-8f9b-50c6bae06c75)
- [483 - 2021-11-09](https://www.keypedia.com/records/483/advanced-accelerator-applications-usa-inc/2d4952fc-3dbf-493f-b61d-804b6d843cf4)
- [483 - 2022-11-03](https://www.keypedia.com/records/483/advanced-accelerator-applications-usa-inc/dca157da-4090-4425-9695-225221971a59)
- [EIR - 2023-08-25](https://www.keypedia.com/records/eir/advanced-accelerator-applications-usa-inc/f4d188da-50ef-46a4-8dce-31c7a01f16c7)

## Related Officers

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

Company: https://www.keypedia.com/companies/advanced-accelerator-applications-usa-inc/ccfc70b0-8949-4d64-8e92-b725c1f0d81f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248