# FDA 483 - ENDO USA, Inc. - October 18, 2021

Source: https://www.globalkeysolutions.net/records/483/endo-usa-inc/bc42b7b8-b606-43d6-9f83-1afe317d5482

> FDA 483 for ENDO USA, Inc. on October 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2021-10-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of PAR Sterile Products LLC in Rochester, MI, revealed significant deficiencies in their aseptic manufacturing processes and quality control systems. Observations included inadequate disinfectant efficacy studies, recurring HEPA filter failures without proper investigation, and a lack of accessible handwashing facilities. Additionally, the firm's environmental monitoring software was found to default to zero values, potentially masking actual contamination.

## Related Documents

- [483 - 2019-04-15](https://www.globalkeysolutions.net/records/483/endo-usa-inc/35e87fe3-12a5-4f62-8497-b112609447cd)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/endo-usa-inc/cd434a60-f760-4174-bc93-90d668d3e834)
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- [483 - 2025-10-20](https://www.globalkeysolutions.net/records/483/endo-usa-inc/2f9d2320-d4c6-4b06-9da5-5a58dc371f64)

## Related Officers

- [Compliance Officer at FDA](https://www.globalkeysolutions.net/people/lauren-m-lilly/41582ad0-67b1-4c60-99e2-c1e3c63811c2)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

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

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