# FDA 483 - Aurobindo Pharma USA Inc - May 15, 2024

Source: https://www.globalkeysolutions.net/records/483/aurobindo-pharma-usa-inc/51f91a8f-0ef6-4350-95ac-a9a7c46f8d32

> FDA 483 for Aurobindo Pharma USA Inc on May 15, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aurobindo Pharma USA Inc
- Inspection Date: 2024-05-15
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Aurobindo Pharma USA Inc. in East Windsor, NJ, received a Form 483 following an inspection that identified significant deficiencies in its Drug Supply Chain Security Act (DSCSA) compliance systems. The firm failed to establish adequate procedures for identifying, investigating, and notifying authorities about suspect or illegitimate drug products. Additionally, the company did not report a cargo theft involving prescription drugs to the FDA within the required 24-hour timeframe.

## Related Documents

- [483 - 2024-05-13](https://www.globalkeysolutions.net/records/483/aurobindo-pharma-usa-inc/23d87088-0c57-415a-b47d-edecbaeb8f2b)

## Related Officers

- [Drug Investigator](https://www.globalkeysolutions.net/people/samir-c-gala/904c34ee-013d-4663-a87a-9cbdbcf2b40e)

Company: https://www.globalkeysolutions.net/companies/aurobindo-pharma-usa-inc/a8dbf5ca-1af1-432a-85b6-5a0c7499eaa5

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