Drugs

CGMP Violations in Hebei Yuxing Inspection

An 8/17-21/15 FDA inspection at Hebei Yuxing Bio-Engineering Co., Hebei, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients, according to a 9/6 Warning Letter. Specific violations noted included:

failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards;
failure to follow and document laboratory controls at the time of performance, and to document and explain any departures from laboratory procedures; and
failure of the quality unit to ensure that all critical deviations are investigated and resolved.

In the letter, FDA says that 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 and recommends retaining a qualified consultant to assist in remediation. The letter details a lengthy list of information items the agency wants from the company in its response.

FDA placed the firm on an Import Alert as of 7/8. Hebei 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 remediation.

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