# FDA 483 - Small Beginnings, Inc. - June 23, 2021

Source: https://www.globalkeysolutions.net/records/483/small-beginnings-inc/a322c403-f21d-4493-a78b-7edac1e21cd4

> FDA 483 for Small Beginnings, Inc. on June 23, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Small Beginnings, Inc.
- Inspection Date: 2021-06-23
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Small Beginnings, Inc., a medical device manufacturer in Hesperia, CA, revealed two significant quality system deficiencies. The firm lacked adequate procedures for controlling nonconforming product and for conducting quality audits, and had not performed any audits as required. These observations indicate a fundamental breakdown in establishing and maintaining a compliant quality system.

## Related Officers

- [Juanj Wu](https://www.globalkeysolutions.net/people/juanj-wu/0d3e8970-b524-49f6-a307-079091b3c91d)

Company: https://www.globalkeysolutions.net/companies/small-beginnings-inc/b29eb2ca-259b-455e-a1fa-81ba9028926f

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