483
Maxkron Machine, LLCMaxkron Machine, LLC – FDA 483, May 13, 2022
Record Details
Maxkron Machine, LLC, a medical device manufacturer in Valencia, CA, was inspected by the FDA. The inspection revealed that the firm failed to document process validation activities and their results for CNC machines used in manufacturing Class II Medical Devices. This indicates a deficiency in their quality system regarding equipment validation and record-keeping.
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ID · 18fa1473-2a07-4651-a736-c6a837bf5675
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