# FDA 483 - ENDO USA, Inc. - April 15, 2019

Source: https://www.keypedia.com/records/483/endo-usa-inc/35e87fe3-12a5-4f62-8497-b112609447cd

> FDA 483 for ENDO USA, Inc. on April 15, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2019-04-15
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: PAR Sterile Products LLC in Rochester, MI, a sterile drug manufacturer, was cited for deficiencies in its batch production and control records. The inspection revealed a lack of complete documentation for significant manufacturing steps, including missing verification signatures, incomplete activity records, and out-of-order line stoppage logs. These issues indicate a failure to maintain adequate control over critical production data.

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## Related Officers

- [Amy Graf](https://www.keypedia.com/people/amy-graf/0d21b7b0-0137-47a1-b014-70e7391bc845)
- [investigator](https://www.keypedia.com/people/joseph-t-madak/85a0e12a-6130-4f04-91ee-bb5351081b8a)
- [investigator](https://www.keypedia.com/people/shirshendu-k-deb/d8e51b5d-e39c-46c5-893d-b01261babec4)
- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)

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