FDA 483 - Anigan, Inc. - May 23, 2019

Anigan, Inc., a medical device manufacturer in San Ramon, CA, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed inadequate documentation of design verification results, including inappropriate test methods for product specifications. Additionally, the firm failed to adequately document the results of its design risk analysis, with identified risk control measures not accurately reflecting methods to control hazards like bacterial contamination.