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New FDA Warning Letter

2016-05-18 20:45:00| Happi Breaking News

NJ-based firm cited for violation of Federal Food, Drug, and Cosmetic Act and insanitary practices.

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FDA Sends Warning Letter to Gilchrist & Soames

2016-03-30 14:04:00| Happi Breaking News

Inspection in Indiana turns up microbial contamination, insanitary practices.

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New, stronger FDA warning for Essure birth control implant

2016-03-01 00:51:02| Chemicals - Topix.net

This Wednesday, May 13, 2015, file photo, shows the North American headquarters of Bayer Healthcare in Whippany, N.J. The Food and Drug Administration announced Monday, Feb. 29, 2016, it plans to warn consumers more strongly about Essure, a contraceptive implant that drew thousands of complaints from women reporting chronic pain, bleeding and other health problems. The FDA is requiring manufacturer Bayer to conduct studies of the device to further assess its risks in different groups of women.

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FDA Issues Warning Letters\n

2015-12-16 06:00:00| Happi Breaking News

Dr. Brandt and Episcience hear from the Agency.

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India's Dr Reddy's gets FDA warning letter for three drug plants

2015-11-06 07:48:12| Biotech - Topix.net

MUMBAI: Dr Reddy's Laboratories Ltd, India's second-largest drugmaker by sales, received a warning letter from the U.S. Food and Drug Administration over inadequate quality control procedures at three manufacturing plants in India. Dr Reddy's shares fell as much as 12 percent in early trade to their lowest level since July 30. The warning letter was issued by the FDA to Dr Reddy's on Thursday for its Srikakulam, Miryalaguda and Duvvada drug manufacturing plants - all based in southern India.

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