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Elan consultants inspect Athlone facility following FDA warning letter on cGMP violations.

Executive Summary

ELAN ATHLONE FACILITY INSPECTED BY THIRD-PARTY GMP CONSULTANTS in response to a July 12 FDA warning letter, the Irish company said Aug. 9. In the letter, the agency suggested that "since FDA has conducted four inspections of your firm in two years and has repeatedly found significant deviations" from current Good Manufacturing Practices regulations, "you may wish to consider obtaining guidance on meeting requirements from outside your firm." FDA also recommended "that you evaluate your facility on a global basis for cGMP compliance."
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PS026659

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