# FDA 483 - ENDO USA, Inc. - June 05, 2025

Source: https://www.keypedia.com/records/483/endo-usa-inc/47c8a26f-ab58-4b6b-b78a-4e26fd6d36c3

> FDA 483 for ENDO USA, Inc. on June 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2025-06-05
- Product Type: biologics
- Office Name: Detroit District Office
- Summary: ENDX USA, Inc., a biological drug manufacturer in Rochester, MI, was inspected by the FDA. The inspection revealed a critical issue where procedures designed to prevent microbiological contamination of sterile drug products were not followed. This was evidenced by operators exhibiting non-compliant behaviors, such as talking and making non-deliberate hand movements, in a Grade (b) (4) manufacturing area during filling operations, indicating a potential risk to product sterility.

## Related Documents

- [483 - 2019-04-15](https://www.keypedia.com/records/483/endo-usa-inc/35e87fe3-12a5-4f62-8497-b112609447cd)
- [483 - Unknown Date](https://www.keypedia.com/records/483/endo-usa-inc/cd434a60-f760-4174-bc93-90d668d3e834)
- [483 - 2021-10-18](https://www.keypedia.com/records/483/endo-usa-inc/bc42b7b8-b606-43d6-9f83-1afe317d5482)
- [483 - 2023-04-14](https://www.keypedia.com/records/483/endo-usa-inc/51dea78b-5586-447a-a96e-6d6017dfe49d)
- [483 - 2025-10-20](https://www.keypedia.com/records/483/endo-usa-inc/2f9d2320-d4c6-4b06-9da5-5a58dc371f64)

## Related Officers

- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

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