Drugs

CGMP Deviations at Zhejiang Huahai

A 7/23-8/3 FDA inspection at Zhejiang Huahai Pharmaceutical Co., Taizhou Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). An 11/29 Warning Letter said specific deviations were:

failure of the quality unit to ensure that quality-related complaints are investigated and resolved; and
failure to evaluate the potential effect that changes in the manufacturing process may have on the quality of the firm’s API.

The agency says that based on the nature of the deviations identified at the firm, it strongly recommends that the company engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It also refers the company to FDA resources to help it establish and follow CGMP-compliant quality systems.

The firm was placed on an FDA import alert 9/28. It was told to respond with a list of specific steps taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.

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