Processing Magazine

Merck gets warning by FDA on vaccine plant’s problems

May 1, 2008
The Wall Street Journal is reporting that the Food and Drug Administration sent a warning letter to Merck & Co., saying that the agency''s investigators found manufacturing deficiencies at its vaccine plant located in West Point, Pa.

The products made there include cervical-cancer vaccine Gardasil and certain childhood vaccines.

The FDA letter, which was dated April 28, stems from an agency inspection conducted between Nov. 26, 2007, and Jan. 17, 2008.

FDA officials issued the warning letter after concluding Merck''s response to that inspection report "was inadequate to address the serious deviations noted."

Among the FDA''s findings were that Merck failed to establish adequate written procedures describing the handling of all written and oral complaints about a drug product.

The FDA said it doesn''t believe the issues identified in the letter will affect the safety of the vaccines manufactured by Merck.

The FDA requested a meeting with Merck senior management to further discuss the issues and Merck''s proposed response to them.

Some of the inspection''s findings were detailed recently in an article in the Philadelphia Inquirer.