# FDA 483 - Recibio Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/recibio-inc/1c5facca-7fe8-45f0-b178-c2c5fe54ca23

> FDA 483 for Recibio Inc. on Unknown Date. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Recibio Inc.
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Recibio Inc. in Richmond, TX, a device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed a lack of quality audits and incomplete documentation for the design control of their Class II CeaLogic Specimen Collection Kit. These issues indicate failures in ensuring proper design review, verification, and validation processes.

## Related Officers

- [Amber Smith, R.S. Sanitarian II](https://www.keypedia.com/people/amber-smith-rs-sanitarian-ii/e51c4c15-a95d-406f-ab3c-17a8b966bee3)

Company: https://www.keypedia.com/companies/recibio-inc/393283c3-840b-43ab-845b-a97a3abcf697

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