Drugs

Beijing Taiyang Refused, Limited FDA Inspection

FDA says that Beijing Taiyang Pharmaceutical Co., Beijing, China, limited and/or refused an FDA inspection on 11/16/15. A 10/19 Warning Letter says the firm’s drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator has limited and refused inspection. The investigators also determined that the company’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to current good manufacturing practice. Specific deviations found during the inspection include:

delaying, denying, or limiting an inspection, or refusing to permit an FDA inspection;
failing to maintain complete data from all laboratory tests conducted to ensure compliance with established specifications and standards;
failing to ensure that all quality-related activities are recorded at the time they are performed; and
failing to maintain batch production and laboratory control records to determine compliance with established active pharmaceutical ingredient specifications before a batch is released or distributed.

The letter says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. FDA recommends the company retain a qualified consultant to assist in its remediation. Beijing Taiyang was told to submit a comprehensive investigation into the extent of inaccuracies in data records and reporting, a current assessment of the potential effects of the observed failures on the quality of its drugs, and a management strategy including details of a global corrective action and preventive action plan.

The firm was placed on import alerts on 4/28 and 4/29. It was told to respond with a list of steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion of the steps.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome