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

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.