# FDA 483 - Advanced Accelerator Applications USA, Inc. - November 09, 2021

Source: https://www.keypedia.com/records/483/advanced-accelerator-applications-usa-inc/2d4952fc-3dbf-493f-b61d-804b6d843cf4

> FDA 483 for Advanced Accelerator Applications USA, Inc. on November 09, 2021. 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: 2021-11-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Advanced Accelerator Applications USA, Inc. in Millburn, NJ, a sterile drug product manufacturer, was cited for significant deficiencies in its quality control, investigation, and reporting systems. The inspection revealed failures to notify customers about out-of-specification or compromised batches of LUTATHERA, inadequate investigations into production discrepancies, and a lack of timely field alert reports. Additional concerns included deteriorating equipment surfaces, incomplete master batch records, poor equipment cleaning logs, and insufficient raw material supplier qualification and testing.

## Related Documents

- [EIR - 2020-08-18](https://www.keypedia.com/records/eir/advanced-accelerator-applications-usa-inc/8766918a-8ced-4675-8f9b-50c6bae06c75)
- [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)
- [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)
- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

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