Drugs

CGMP Issues Found in China’s Zhejiang Medical

A 6/15-6/18 FDA inspection at Zhejiang Medicine Co., Xinchang Pharmaceutical Factory, Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients, according to an 8/4 Warning Letter. Specific deviations included:

failing to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards;
failing to exercise sufficient controls over computerized systems to prevent unauthorized access of changes to data, and failing to provide adequate controls to prevent omissions of data; and
failing to record activities at the time they are performed.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” FDA wrote. “We strongly recommend that you retain a qualified consultant to assist in your remediation.” The letter lists detailed reports and analyses requested in response to the letter.

The company was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence.

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

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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