# FDA 483 - ENDO USA, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/endo-usa-inc/cd434a60-f760-4174-bc93-90d668d3e834

> FDA 483 for ENDO USA, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Par Sterile Products, LLC in Rochester, Michigan, a drug product manufacturer, revealed significant deficiencies in manufacturing process validation and quality unit procedures. Observations included unvalidated capping/crimping machines, inadequate personnel monitoring for aseptic gloves, and a lack of written procedures for decontamination and aseptic processing behavior. These issues indicate a need for improved control and documentation of critical manufacturing operations.

## Related Documents

- [483 - 2019-04-15](https://www.keypedia.com/records/483/endo-usa-inc/35e87fe3-12a5-4f62-8497-b112609447cd)
- [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 - 2025-06-05](https://www.keypedia.com/records/483/endo-usa-inc/47c8a26f-ab58-4b6b-b78a-4e26fd6d36c3)
- [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)
- [Investigator](https://www.keypedia.com/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)
- [Lindsey Brown](https://www.keypedia.com/people/lindsey-brown/ff47f714-146f-474e-a6b8-2cf14c67dd4f)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd