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Biotech / Medical : Merck -- Ignore unavailable to you. Want to Upgrade?

To: John Carragher who wrote (920)	7/8/1998 8:41:00 AM
From: John Carragher	Respond to of 1580

Dow Jones Newswires -- July 7, 1998 FDA Warns Merck About Manufacturing Procedures By OTESA MIDDLETON Dow Jones Newswires WASHINGTON -- The U.S. Food and Drug Administration sent Merck & Co. (MRK) a warning letter about its manufacturing process for five drugs, including its popular heartburn medication Pepcid. The warning letter, dated June 16 and released to the public Tuesday, said the company failed to follow its established procedures to ensure the stability of the drugs at its West Point, Pa. facility. Other drugs mentioned in the FDA's letter are: antibiotic Noroxin, eye medication Timoptic, ulcer medicine Prilosec and allergy drug Decadron. In the eight-page letter, the FDA also said Merck's "quality assurance unit was not proactive" in removing defective equipment after atypical reports were received. The FDA also cited the company for "failing to ensure that manufacturing facilities are maintained in a clean and sanitary condition in that, on April 29, 1998, two lots of granulating solution for Prilosec delayed-release capsules were exposed to potential debris from on-going construction activities." The FDA's warning letter said it received a letter from Merck dated May 27 explaining how the company planned to correct things cited during an inspection of the West Point facility from April 6 to May 12. Although Merck addressed some problems pointed out during inspection, the FDA said it didn't satisfactorily address other observations. Carol Goodrich, a Merck spokeswoman, said the company responded to the FDA's warnign letter July 2. "The FDA's letter addressed three principal issues: stability testing, equipment qualifications and procedures to control contractor access to manufacturing areas," Goodrich said. Although Goodrich didn't specify how the company planned to meet the FDA's requirements, she said Merck provided the agency with "a formal written response." -Otesa Middleton; 202-862-6654 Briefing Book for: MRK Return to top of page \| Format for printing Copyright c 1998 Dow Jones & Company, Inc. All Rights Reserved.