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September 10, 2024
10
Sep

Warning Letter: Design Change and Validation

September 10, 2024
WARNING LETTER Micro-X Ltd. was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals: CMS# 692084 Micro-X Ltd.. 6 MAB Eastern Promenade, Unit 14Tonsley SA 5042Australia Dates:  May 20, 2024, through May 23, 2024 Inspection Issue(s): The report states, “This inspection revealed that these devices are adulterated within the...
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