# FDA 483 - Medical Illumination International, Inc - January 29, 2025

Source: https://www.globalkeysolutions.net/records/483/medical-illumination-international-inc/86e1ec6b-604b-44a8-92da-49271a7d5ccf

> FDA 483 for Medical Illumination International, Inc on January 29, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Medical Illumination International, Inc
- Inspection Date: 2025-01-29
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: Medical Illumination International, Inc. in Chatsworth, CA, a medical device manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate documentation of process validation activities for class II medical devices. Additionally, procedures for design transfer were not adequately established, resulting in a device master record (DMR) not being released before manufacturing operations began.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/medical-illumination-international-inc/02949a55-0f64-4249-b2f6-df8d6aa4c573

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b