PharMedium To Remediate And Operate Outsourcing Facilities Under FDA Consent Decree
Outsourcer PharMedium has agreed to suspend sterile drug compounding at one of its facilities until it remedies GMP problems under the terms of a consent decree. A federal complaint said that the firm ignored a slew of microbiological and quality problems.
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HHS Inspector General paints a more positive picture of FDA’s efforts to bring high-volume compounding into better regulatory control than the agency’s own statements might suggest. That could mean the initiative is able to recede a bit from the top-priority status it has had at the agency for almost a decade.
Site-based metrics praised; lot acceptance rates, invalidated OOS rates discouraged. Agency official admits some proposed metrics were “not the best.”