FDA 483 - NeuroCareAI, Inc. - December 12, 2025
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NeuroCareAI, Inc. dba SaveLife AI, Inc. in Prosper, TX, received a Form FDA 483 with four observations following an inspection. The firm was cited for significant deficiencies in its quality system, including a lack of internal quality audits and inadequate supplier management. Additionally, issues were noted with the establishment of installation and test procedures, and the failure to implement unique device identifiers for its Neurocare ICH standalone software medical device.
ID · f7273be9-91eb-463d-bf71-0d5c45d5d89b