# FDA 483 - Prestige Medical - January 13, 2023

Source: https://www.globalkeysolutions.net/records/483/prestige-medical/885f131c-e9a6-4cbe-927d-5de37506618f

> FDA 483 for Prestige Medical on January 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Prestige Medical
- Inspection Date: 2023-01-13
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: This FDA Form 483 was issued to Prestige Medical, a medical device manufacturer in Northridge, CA, following an inspection. Observations noted deficiencies in the firm's procedures for controlling nonconforming product, including tagging, segregation, and rework. Additionally, the firm failed to adequately maintain device history records by not including primary identification labels and control numbers.

## Related Documents

- [483 - 2019-10-24](https://www.globalkeysolutions.net/records/483/prestige-medical/61d5575b-ce36-449a-b0ec-c58f463151dc)

## Related Officers

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

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