# FDA 483 - Nielsen Biosciences, Inc - April 17, 2025

Source: https://www.globalkeysolutions.net/records/483/nielsen-biosciences-inc/cc728f8f-858c-4b4f-b913-cbe13e1f1356

> FDA 483 for Nielsen Biosciences, Inc on April 17, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nielsen Biosciences, Inc
- Inspection Date: 2025-04-17
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: Nielsen Biosciences, Inc. in San Diego, CA, a licensed biological drug manufacturer, was inspected and cited for multiple deficiencies in its quality system. Key issues include failures in maintaining adequate records for annual product reviews, significant delays in closing and initiating deviations and CAPAs, and a lack of thorough investigation into unexplained discrepancies. Additionally, the firm was found to have inadequate qualified personnel for critical testing and lacked established procedures for reporting biological product deviations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [Investigator](https://www.globalkeysolutions.net/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.globalkeysolutions.net/companies/nielsen-biosciences-inc/8ed7ad7b-f2c5-4d03-b572-6ef0f74b36f4

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b