483
Virak Orthopedics LLCVirak Orthopedics LLC – FDA 483, Mar 27, 2026
Record Details
An FDA inspection of Virak Orthopedics LLC in Madison, NJ, a specification developer and repackager/relabeler, revealed two significant observations regarding their quality system. The firm failed to adequately document procedures for timely complaint handling and for reviewing the effectiveness of corrective actions. These deficiencies indicate a need for improved adherence to quality system regulations.
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