# FDA 483 - IndeCon, Inc. - December 12, 2024

Source: https://www.keypedia.com/records/483/indecon-inc/ebd41097-1d7f-4af8-a96c-1e66f0ca86d3

> FDA 483 for IndeCon, Inc. on December 12, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IndeCon, Inc.
- Inspection Date: 2024-12-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of IndeCon, Inc. in Dallas, TX, an HCT/P distributor, revealed significant deficiencies in record-keeping practices. Observations included failures to concurrently document incoming product evaluations, record HCT/P storage temperatures, and retain HCT/P-related records for the required duration. These issues indicate a lack of adequate control over critical operational and quality processes.

## Related Documents

- [483 - 2024-12-12](https://www.keypedia.com/records/483/indecon-inc/db291714-ce65-4a64-bdee-75da2f56c89f)

## Related Officers

- [Narning V Briones](https://www.keypedia.com/people/narning-v-briones/d3d10e10-2fd6-494e-974a-555d559b5001)
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Company: https://www.keypedia.com/companies/indecon-inc/4e69c625-7949-4a8f-8792-1c94387f1de7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab