WHEN IS PARAMETRIC RELEASE USING TERMINAL STERILIZATION NOT STERILIZATION 3. "Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to … [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...]
