FDA 483 - Nu Dimension Tech Ventures, Llc - May 04, 2022

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.