FDA Sends Warning Letter To Merck About Manufacturing Problems At Pa. Plant

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Immune System / Vaccines;  Women's Health / Gynecology
Article Date: 05 May 2008 - 6:00 PDT

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FDA on April 28 sent a warning letter to Merck officials informing them that agency investigators discovered manufacturing deficiencies at the company's vaccine plant in West Point, Pa., the Wall Street Journal reports. The vaccines produced there include Gardasil, the cervical cancer vaccine, as well as certain childhood vaccines (Loftus, Wall Street Journal, 5/1). According to the nine-page letter, FDA found "significant objectionable conditions" in the production of vaccines and drug ingredients during repeated inspections of the facility (Johnson, AP/San Francisco Chronicle, 4/30).

The Philadelphia Inquirer reports that FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008, and found 45 areas of concern (Stark, Philadelphia Inquirer, 5/1). FDA issued the letter after officials determined that Merck's response to the inspection report "was inadequate to address the serious deviations noted." According to the Journal, investigators determined that Merck had not established adequate written procedures for the handling of complaints regarding an unnamed drug product (Wall Street Journal, 5/1). In addition, Merck officials did not adequately investigate why some batches of vaccines failed to meet specifications.

According to FDA, the agency "does not believe that the issues identified will affect the safety of the vaccines" made at the plant or their availability. The letter gives Merck 15 days to outline an action plan to correct the violations and submit it to FDA (AP/San Francisco Chronicle, 4/30). According to the Inquirer, if FDA's concerns are not addressed, the agency could take court action against Merck and could close the plant or individual production lines (Philadelphia Inquirer, 5/1).

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