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

Source: https://www.keypedia.com/records/483/indecon-inc/db291714-ce65-4a64-bdee-75da2f56c89f

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

---

## Details

- Record Type: 483
- Company Name: IndeCon, Inc.
- Inspection Date: 2024-12-12
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of IndeCon, Inc. in Dallas, TX, an HCT/P distributor, revealed significant deficiencies in record-keeping and storage temperature monitoring. The firm failed to maintain records concurrently, document incoming product evaluations, record HCT/P storage temperatures, and retain all required records for the specified duration. These issues indicate a lack of adequate control over critical processes for human cells, tissues, and cellular and tissue-based products.

## Related Officers

- [Nerming V. Briones](https://www.keypedia.com/people/nerming-v-briones/b2d9e685-a627-4f9e-854c-0588865fd1b6)
- [Investigator](https://www.keypedia.com/people/elisa-m-fleming/bfb8308a-9b37-4051-90f2-66066c26e1f4)

Company: https://www.keypedia.com/companies/indecon-inc/4e69c625-7949-4a8f-8792-1c94387f1de7

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9