# Onanon Inc – FDA 483, Apr 21, 2026

Source: https://www.keypedia.com/records/483/onanon-inc/c90818b4-06d2-4953-bd8a-72bcb8441dd3

> FDA 483 for Onanon Inc on April 21, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Onanon Inc
- Inspection Date: 2026-04-21
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Onanon Inc, a contract manufacturer in Milpitas, CA, revealed five significant deficiencies in their quality system. The observations primarily concern inadequate documentation and procedures for risk management, complaint handling, medical device reporting, nonconforming product records, and supplier monitoring. These issues indicate a need for the firm to strengthen its internal quality control processes.

## Related Officers

- [Kenya Destin](https://www.keypedia.com/people/kenya-destin/1a367d64-8171-4dfd-bb1f-78d8b96a99f5)

Company: https://www.keypedia.com/companies/onanon-inc/39e5fb13-9215-4de8-99c3-a9a23815e19f

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b