# FDA 483 - Neogen Culture Media - April 07, 2025

Source: https://www.keypedia.com/records/483/neogen-culture-media/d10facd9-bca5-459c-859a-bddf115d0f7b

> FDA 483 for Neogen Culture Media on April 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neogen Culture Media
- Inspection Date: 2025-04-07
- Product Type: device
- Office Name: Detroit District Office
- Summary: Neogen Corporation in Lansing, MI, a medical device establishment, was cited with eight observations during an FDA inspection. The findings indicate significant deficiencies across multiple quality system areas, including inadequate corrective and preventive action procedures, insufficient equipment validation, and failures in complaint handling and supplier management. Several observations, particularly regarding CAPA and process validation, were noted as repeat findings from previous inspections, highlighting persistent systemic issues.

## Related Documents

- [483 - 2025-04-07](https://www.keypedia.com/records/483/neogen-culture-media/3576a69e-7592-4909-ba12-94e908187dc0)

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/neogen-culture-media/05adf193-8de2-4afe-99cf-f25c1d36f24b

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03