# FDA 483 - Beyond International Inc - February 28, 2024

Source: https://www.keypedia.com/records/483/beyond-international-inc/c8331da1-4cd1-49c6-b479-0976479ab1a9

> FDA 483 for Beyond International Inc on February 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beyond International Inc
- Inspection Date: 2024-02-28
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Beyond International Inc, a medical device manufacturer in Sugar Land, TX, revealed significant deficiencies across its quality system. Observations included a lack of proper certification for dental lasers, failure to submit required annual reports, and missing Unique Device Identifiers on several Class I medical devices. The firm also demonstrated inadequate procedures for Medical Device Reporting, corrective and preventive actions, control of nonconforming products, and servicing activities.

## Related Documents

- [483 - 2024-02-28](https://www.keypedia.com/records/483/beyond-international-inc/6461d5a5-4cce-481d-a7f4-367fc6f2242a)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/beyond-international-inc/4b964eef-fddc-4fd2-a16e-2e7a9e563a33

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab