The U.S. Food and Drug Administration (FDA) inspected Daito Kasei Kogyo Co., LTD. from July 18 to 21, 2017. They subsequently were placed on an Import Alert 66-40 on October 25, 2017 and received a Warning Letter on January 19, 2018. During the inspection, the investigator observed specific deviations including, but not limited to, the following. Failure to … [Read more...]
ALLURE LABS RECEIVES WARNING LETTER (5/24/11)
ALLURE LABS’ CITED FOR FAILURE TO CALCULATE MICROBIOLOGICAL DILUTION FACTOR CORRECTLY WITHIN PRODUCT LEADS TO PRODUCT FAILURE We have reviewed your firm’s response dated December 12, 2010, and note that it lacks sufficient corrective actions. We acknowledge your second written response, dated February 3, 2011, to the Form FDA 483. However, because this response was received … [Read more...]
