# FDA 483 - ENDO USA, Inc. - April 14, 2023

Source: https://www.keypedia.com/records/483/endo-usa-inc/a95cae7d-511c-43d5-81a1-dba506cb0c81

> FDA 483 for ENDO USA, Inc. on April 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2023-04-14
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Par Sterile Products LLC in Rochester, MI, revealed significant deficiencies in aseptic processing for sterile drug products. The firm failed to follow procedures for documentation of interventions, cleaning and disinfection, and aseptic setup and filling operations. These issues collectively indicate a high risk of microbiological contamination of sterile products.

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## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [Jodi Castelveter](https://www.keypedia.com/people/jodi-castelveter/3c70667d-2f6f-4e3d-a3fa-f32b98f6f9d1)

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

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c