Merck warned about manufacturing plant
Pharma Compliance Alert, May 7, 2008
FDA investigators documented “significant deviations from current good manufacturing practices” at a Merck plant near Philadelphia that makes vaccines including Gardasil, according to a warning letter posted by the FDA.
According to the warning letter, between November 2007 and January 2008, Merck failed to:
- Thoroughly investigate any batch or any of its components that did not meet any of its specifications
- Establish adequate written procedures for handling all written and oral complaints regarding a drug product
- Assure written procedures are in place for production and process controls
- Assure equipment is calibrated, inspected, or checked according to a written program designed to ensure proper performance
- Exercise appropriate controls over computer or related systems
- Establish test procedures or other laboratory control mechanisms designed to ensure drug products conform to appropriate standards
The FDA requested a meeting with senior management at Merck to discuss the issues raised in the letter. The FDA also asked for a written response within 15 days.
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