483
Micro Current Technology, Inc.Micro Current Technology, Inc. – FDA 483, Jan 28, 2019
Record Details
An FDA inspection of Micro Current Technology, Inc., a manufacturer of Class 2 medical devices (TENS), identified significant deficiencies. The firm was cited for not having sampling plans based on valid statistical rationale, which was a recurring observation. Additionally, procedures for design changes were not adequately established, and validation of device software was incomplete.
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