483
Virak Orthopedics LLCVirak Orthopedics LLC – FDA 483, Aug 25, 2023
Record Details
Virak Orthopedics LLC, a packer and distributor, was cited with two observations during an FDA inspection. The firm failed to adequately re-evaluate suppliers according to its established procedures. Additionally, internal quality audits were not performed as required by the firm's own SOPs, with the last audit dating back to 2017.
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