# FDA 483 - ENDO Pharmaceuticals Solutions, Inc. - October 23, 2018

Source: https://www.keypedia.com/records/483/endo-pharmaceuticals-solutions-inc/0470733a-57bb-4e4b-9ba6-c481522df941

> FDA 483 for ENDO Pharmaceuticals Solutions, Inc. on October 23, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ENDO Pharmaceuticals Solutions, Inc.
- Inspection Date: 2018-10-23
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: ENDO Pharmaceuticals Solutions, Inc. in Cranbury, NJ, received a Form 483 with five observations highlighting significant deficiencies. The inspection revealed issues in preventing microbiological contamination, maintaining aseptic processing areas, and ensuring adequate laboratory controls for product testing. Additionally, the firm failed to thoroughly investigate out-of-specification results for drug product components, which were linked to patient complaints for distributed implant lots.

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## Related Officers

- [investigator](https://www.keypedia.com/people/maria-estrella/36cf1d7d-41af-4f40-9de4-174a82a31a56)
- [Adetutu M. Gidado](https://www.keypedia.com/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.keypedia.com/companies/endo-pharmaceuticals-solutions-inc/73c5da1a-04ad-4b56-9fae-f0a1371df51f

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248