# FDA 483 - Prestige Medical - October 24, 2019

Source: https://www.globalkeysolutions.net/records/483/prestige-medical/61d5575b-ce36-449a-b0ec-c58f463151dc

> FDA 483 for Prestige Medical on October 24, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prestige Medical
- Inspection Date: 2019-10-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Prestige Medical, a Class II medical device manufacturer in Northridge, CA, received a Form 483 for several quality system deficiencies. The inspection revealed issues with management review of the quality system, inadequate complaint handling, and insufficient supplier record maintenance. Additionally, the firm failed to properly identify non-conforming products, indicating a need for comprehensive quality management improvements.

## Related Documents

- [483 - 2023-01-13](https://www.globalkeysolutions.net/records/483/prestige-medical/885f131c-e9a6-4cbe-927d-5de37506618f)

## Related Officers

- [Kelvin Cheung](https://www.globalkeysolutions.net/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.globalkeysolutions.net/companies/prestige-medical/1e0afc98-ace1-46b8-8406-09dfcf2aa05e

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6