American Laser Healthcare CorpJuly 17, 2019

FDA 483 - American Laser Healthcare Corp - July 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.

Company: American Laser Healthcare Corp
Inspection Date: July 17, 2019
Product Type: Device
Office: Division of Pharmaceutical Quality Operations IV
Person: Matthew D. Schnittker

Open in Dashboard

ID · 828999c1-5a67-48cc-be3f-14093f3983b0