483
Pourang Bral, DDS, LLC DbA Painless WorldPourang Bral, DDS, LLC DbA Painless World – FDA 483, Apr 24, 2026
Record Details
An FDA inspection of Pourang Bral, DDS, LLC DBA Painless World in Jersey City, NJ, revealed significant deficiencies in its quality management system for the Noodle - TENS device. The firm lacked documented and implemented procedures for critical areas such as management reviews, internal audits, supplier control, complaint handling, CAPA, and design control. Additionally, the firm's Medical Device Reporting procedures were found to be inadequate and not fully implemented.
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