# FDA 483 - JDJ ECOM LLC, dba Alpha Strong US - October 06, 2022

Source: https://www.keypedia.com/records/483/jdj-ecom-llc-dba-alpha-strong-us/51e51c21-3322-45ab-af6a-e00bea5d1f15

> FDA 483 for JDJ ECOM LLC, dba Alpha Strong US on October 06, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JDJ ECOM LLC, dba Alpha Strong US
- Inspection Date: 2022-10-06
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: JDJ ECOM LLC, dba Alpha Strong US, an importer/dealer in Doral, FL, was cited for multiple deficiencies related to its Spear Laser product. The inspection revealed significant non-compliance with laser product classification, incorrect and missing labeling, and failures to submit required product and annual reports. These observations indicate serious regulatory violations concerning laser product safety and reporting requirements.

## Related Officers

- [Ashley A. Mutawakkil](https://www.keypedia.com/people/ashley-a-mutawakkil/512be391-fd96-451c-9569-98e43cfba9db)

Company: https://www.keypedia.com/companies/jdj-ecom-llc-dba-alpha-strong-us/aec21ee1-eb4c-438c-a935-11d4b4d8f736

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6