FDA WARNING_LETTER - Merck & Company, Inc. - January 17, 2008

The FDA issued a Warning Letter to Merck and Company, Inc. following an inspection from November 26, 2007, to January 17, 2008, at their West Point, Pennsylvania facility. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components, including Liquid PedvaxHIB?, RECOMBIVAX HB?, ProQuad?, Gardasil?, VAQTA?, and COMVAX?. These violations contravene Section 501(a)(2)(B) of the FD&C Act, requirements of their biologics license application under Section 351 of the PHS Act, and 21 CFR Parts 210 and 211.

Key deficiencies include: - **Inadequate Investigations:** Failure to thoroughly investigate unexplained discrepancies, such as out-of-specification Varivax III, over-pressurization of Zostavax? vials, unassessed product lots affected by shedding fibers, and uninvestigated critical defects in MMR II? lots. - **Complaint Handling:** Inadequate written procedures for handling complaints, specifically regarding lot history for fill lot numbers versus final finish lot numbers. - **Production and Process Controls:** Validation for automated inspection equipment not representative of actual processes, and process control limits for Zostavax? not evaluated as required. - **Equipment Calibration and Maintenance:** Automated inspection