# FDA 483 - ENDO USA, Inc. - October 20, 2025

Source: https://www.keypedia.com/records/483/endo-usa-inc/2f9d2320-d4c6-4b06-9da5-5a58dc371f64

> FDA 483 for ENDO USA, Inc. on October 20, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2025-10-20
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: An FDA inspection of ENDO USA, Inc. in Rochester, MI, a sterile drug manufacturer, revealed significant deficiencies in its manufacturing operations. Observations included inadequately designed equipment leading to aseptic breaches, failures in preventing microbiological contamination through deficient aseptic process simulations and environmental monitoring, and a visual inspection program that could not consistently detect product defects. The firm also failed to thoroughly review unexplained discrepancies, impacting product quality and patient safety.

## Related Documents

- [483 - 2019-04-15](https://www.keypedia.com/records/483/endo-usa-inc/35e87fe3-12a5-4f62-8497-b112609447cd)
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- [483 - 2025-06-05](https://www.keypedia.com/records/483/endo-usa-inc/47c8a26f-ab58-4b6b-b78a-4e26fd6d36c3)

## Related Officers

- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Shannon L. Maisano](https://www.keypedia.com/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)
- [Nicholas J. Presto](https://www.keypedia.com/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)
- [Nicole M. Presto](https://www.keypedia.com/people/nicole-m-presto/8cf63ce6-37b3-46b4-8bf6-cbac9da5622a)
- [Ramia Brzenjy](https://www.keypedia.com/people/ramia-brzenjy/b0e5e3b0-c295-4ec6-845a-95968824c16a)

Company: https://www.keypedia.com/companies/endo-usa-inc/f2df2e47-8303-4a2c-9881-5e2ecef64f22

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03