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

Source: https://www.keypedia.com/records/483/endo-usa-inc/aaf10327-fc58-4ce7-9174-f165fd8d9972

> 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: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of ENDO USA, Inc. in Rochester, MI, a biological drug manufacturer, revealed a significant issue with aseptic processing. Procedures designed to prevent microbiological contamination of sterile drug products were not followed. Specifically, operators were observed talking and moving hands in a fast, non-deliberate motion in Grade (b) (4) manufacturing areas during filling operations, indicating a breakdown in aseptic technique.

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- [483 - 2025-06-05](https://www.keypedia.com/records/483/endo-usa-inc/47c8a26f-ab58-4b6b-b78a-4e26fd6d36c3)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0