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...]
HAMELN PHARMACEUTICALS, HAMELN, GERMANY RECEIVES WARNING LETTER (12/17/12)
IN-HOUSE STERILITY TESTING METHOD NOT EQUIVALENT TO USP<71> During the time frame of June 4 - 14, 2012, the Hameln facility was audited by the FDA. Following the audit, the firm responded on July 4, August 2 and 31, and September 8, 2012. Even with all of these responses, the FDA found that the firm lacked sufficient corrective actions. For … [Read more...]
AMERICAN NATIONAL RED CROSS RECEIVES ADVERSE DETERMINATION LETTER (1/13/12)
FAILURE OF THE ARC TO MEET REQUIREMENTS YIELDS OVER 9 MILLION DOLLAR FINE From April through October 2010, United States Food and Drug Administration (FDA) investigators inspected sixteen American National Red Cross (ARC) Blood Services facilities and observed significant violations of the law, regulations, and the Amended Consent Decree of Permanent Injunction, entered on … [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...]
