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...]