Enclosed are a series of upcoming microbiological webinars which are being offered between now and the end of September. While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing. Just click on the title of each webinar to gain additional information or … [Read more...]
Celltrion Inc, Republic of Korea, Receives Warning Letter for Microbiological/Environmental Issues
The U.S. Food and Drug Administration (FDA) inspected Celltrion Inc, Republic of Korea from May 22 – June 2, 2017. On January 26, 2018 the FDA issued a Warning Letter for microbiological/environmental issues that summarizes significant violations of cGMP for finished pharmaceuticals (see 21 CFR, parts 210/211). Several … [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...]
