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

Source: https://www.keypedia.com/records/483/endo-usa-inc/51dea78b-5586-447a-a96e-6d6017dfe49d

> 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: Division of Pharmaceutical Quality Operations III
- Summary: Par Sterile Products LLC in Rochester, MI, was cited for significant failures in following procedures designed to prevent microbial contamination of sterile drug products. The inspection revealed incomplete documentation of interventions, inadequate cleaning and disinfection practices, and multiple instances of operators not adhering to aseptic techniques during equipment setup and filling operations for Ephedrine Sulfate Injection. These deficiencies indicate a serious lack of control over aseptic processing, potentially compromising product sterility.

## Related Documents

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- [483 - 2025-10-20](https://www.keypedia.com/records/483/endo-usa-inc/2f9d2320-d4c6-4b06-9da5-5a58dc371f64)

## 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)

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