483
American Laser Healthcare CorpAmerican Laser Healthcare Corp – FDA 483, Jul 17, 2019
Record Details
American Laser Healthcare Corp, a medical device manufacturer in Irvine, CA, received one observation during an FDA inspection. The firm failed to perform software validation for the software used to operate their infrared pad device. This indicates a deficiency in their quality system regarding device software control.
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ID · 828999c1-5a67-48cc-be3f-14093f3983b0
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