# FDA 483 - EZGO GROUP INC - December 22, 2021

Source: https://www.keypedia.com/records/483/ezgo-group-inc/ec6f3992-313d-4650-83e0-90cac9423f92

> FDA 483 for EZGO GROUP INC on December 22, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EZGO GROUP INC
- Inspection Date: 2021-12-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of EZGO GROUP INC, an initial importer of Class I and II medical devices in Rancho Cucamonga, CA, revealed significant deficiencies in their quality system. The firm failed to establish fundamental procedures for design control, corrective and preventive actions, complaint handling, and medical device reporting. These observations indicate a lack of basic quality system infrastructure for a medical device importer.

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.keypedia.com/companies/ezgo-group-inc/44a8de19-4c46-4755-a429-923a17d76ba3

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