483
Nu Dimension Tech Ventures, LlcNu Dimension Tech Ventures, Llc – FDA 483, May 4, 2022
Record Details
Nu Dimension Tech Ventures, Llc, a medical device manufacturer in Huffman, TX, received a Form FDA 483 citing multiple quality system deficiencies. The inspection revealed inadequate procedures and documentation across several critical areas, including complaint handling, labeling, software validation, risk analysis, and design controls. A repeat observation was noted for the lack of review and approval of documents prior to issuance.
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ID · c7223dba-b11a-44fb-a5c7-66608f9718a1
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