# FDA 483 - ENDO USA, Inc. - August 09, 2018

Source: https://www.keypedia.com/records/483/endo-usa-inc/b6ded9a6-e663-4d93-856a-a7860d06a8fe

> FDA 483 for ENDO USA, Inc. on August 09, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO USA, Inc.
- Inspection Date: 2018-08-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Par Sterile Products, LLC in Rochester, MI, received a Form FDA 483 with 13 observations during an inspection from July 31 to August 9, 2018. The observations primarily highlight significant deficiencies in aseptic processing, environmental monitoring, contamination control, and quality system procedures, including inadequate investigations, training, and documentation. These issues indicate a lack of assurance in preventing microbiological contamination and ensuring product quality for sterile drug products.

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## Related Officers

- [CSO](https://www.keypedia.com/people/mihaly-s-ligmond/2904ef70-a757-49c7-9ac4-a2c07ee36001)
- [issuing_officer](https://www.keypedia.com/people/omotunde-osunsanmi/41c6ef66-1d5c-4940-8b1f-628da20cde34)

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