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.