# FDA 483 - Advanced Accelerator Applications USA, Inc. - November 03, 2022

Source: https://www.keypedia.com/records/483/advanced-accelerator-applications-usa-inc/dca157da-4090-4425-9695-225221971a59

> FDA 483 for Advanced Accelerator Applications USA, Inc. on November 03, 2022. 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: 2022-11-03
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: The FDA inspected Advanced Accelerator Applications USA, Inc. in Millburn, NJ, a sterile drug manufacturer, and issued a Form 483. The inspection revealed significant deficiencies in production and process controls, including incomplete equipment qualifications and overdue calibrations. Additionally, the quality control unit failed to adequately manage investigations and alarm reviews, and procedures to prevent microbiological contamination were not established, indicating a lack of robust quality systems.

## 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)
- [EIR - 2023-08-25](https://www.keypedia.com/records/eir/advanced-accelerator-applications-usa-inc/f4d188da-50ef-46a4-8dce-31c7a01f16c7)
- [483 - 2024-06-27](https://www.keypedia.com/records/483/advanced-accelerator-applications-usa-inc/8a5d9f11-f3c3-423f-a0f4-9a9174e1f938)

## Related Officers

- [Robin P. Mathew](https://www.keypedia.com/people/robin-p-mathew/35f4a085-58b8-4208-a648-ef2d533e1ece)
- [Mindy M. Chou](https://www.keypedia.com/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)
- [Pharmacist | Consumer Safety Officer](https://www.keypedia.com/people/victoria-spivak/b43d066f-35c1-4d83-9d38-3ba64d77cf31)

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